San Diego, CA (PRWEB) June 11, 2013
Resource4thePeople, in its latest update to consumers affected by operations involving medical devices, today announced new legal options that are being offered involving alleged serious side effects involving Medtronic Infuse bone grafts.
The medical devices have been attracting consumer interest in the wake of a Class 1 Recall by the Food and Drug Administration* and a highly critical report** from a U.S. Senate committee that raised concerns about conflicts of interest because of payments the company made to medical researchers and physicians.
"In response to confusion cited by consumer inquiries, there are now available free consultations involving allegations of medical malpractice in addition to those involving alleged side effects from the Medtronic Infuse Bone Graft," said Resource4thePeople.
"We are finding that some consumers are inquiring about allegations that they underwent surgeries that were not necessary in which they received Medtronic Infuse Bone Graft implants. We are also finding that some patients are alleging that they have had serious health problems as a result of these implants. These may be separate legal issues."
Resource4thePeople also said that it is expanding its national network of legal assistance to now provide these complimentary consultations for both types of inquiries.
“In addition, we will also continue to provide regular updates providing these consumers with information about the legal rights they may have to pursue compensation over allegations of Medtronic Infuse Bone Graft side effects," said Resource4thePeople.
"Among these updates will be the results of an Infuse study conducted by researchers at Yale University, which will provide an independent overview of bone graft products."
HealthPointCapital, in a May 23, 2013 posting,*** said the findings of the review are expected to be released this month. The study was commissioned after stories were published in 2011 in The Spine Journal**** revealing that Infuse bone graft complications were being underreported.
Resource4thePeople said it will continue to track the progress of the review by Yale researchers and post the results as soon as they are made public.
“This will continue to be an area of prime focus for us as we provide consumers legal options involving allegations that the Medtronic Infuse Bone Grafts may have caused serious, life-threatening health problems,” said Resource4thePeople.
“Among the allegations we are investigating are claims from consumers alleging that the Medtronic Infuse Bone Grafts were used improperly in medical operations and caused serious side effects to patients.”
Resource4thePeople also said that its national network of attorneys will continue to offer free consultations to consumers who are alleging they may have suffered severe back and leg pain, infections, bone deterioration, sterility and cancer, among other problems.
In the FDA’s Feb. 16, 2011 Class 1 Recall* of Medtronic Infuse Bone Graft pumps and refill kits, the FDA said the products "may result in patient harm, serious injury, and/or death due to drug overdose or underdose.”
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Resource4thePeople also notes that a federal lawsuit***** was 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.
The lawsuit includes allegations that 88 patients 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 seeking compensation.
The lawsuit claims that "medically unnecessary, experimental spine surgeries" were performed "using falsely and improperly marketed Medtronic medical devices and drugs," according to allegations contained in the court file.
Resource4thePeople also said that the allegations filed in the new lawsuit raise more questions about the relationships between physicians and Medtronic over fees paid to the doctors that have come under criticism** from U.S. Senate Finance Committee investigators.
“The revelations included in the Oct. 25, 2012 report by the Senate Finance Committee involving payments to doctors and the downplaying of dangerous side effects from this medical device have raised serious questions among patients who underwent these surgeries and have contacted us," said Resource4thePeople.
Resource4thePeople said that over the last few months such inquiries have increased as a result of news media reports about the findings of the committee’s investigation into Medtronic’s spending of millions of dollars to doctors and researchers in return for studies favorable to the Infuse device.
The Medtronic Infuse bone graft was approved by the Food and Drug Administration as a sanctioned medical device designed to stimulate spinal bone growth in patients suffering from lower spine degenerative diseases.
*****Case # 1:13cv0202 U.S. District Court, Southern District of Ohio
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