Medtronic Infuse Bone Graft Failure Allegation Lawsuits Update: Resource4thePeople Reports New Research Findings Raise Concerns about Side Effects
Yale University study finds no evidence that Medtronic grafts are more effective than traditional treatments and questions reliability of data provided to researchers. Consumers seeking information about legal rights are still eligible to seek complimentary consultations over allegations of serious side effects.
San Diego, CA (PRWEB) July 05, 2013
Resource4thePeople, in its latest update to consumers affected by operations involving medical devices, today announced that the findings of a two-year study by Yale University researchers have raised concerns about the marketing and safety of Medtronic Infuse bone grafts similar to those included in allegations now being reviewed.
The Yale University study, which was published* June 18, 2013 in the Annals of Internal Medicine, was undertaken as an independent study after the medical devices were the subject 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.
Studies funded by Medtronic underplayed the benefits of the Infuse bone grafts and failed to report many serious side effects, according to both Yale researchers and Senate investigators. The Yale researchers reported such serious side effects as excessive bone growth, male sterility, inflammations and paralysis, according to the report.
“The findings of this study are consistent with some of the allegations that we have been receiving in increasing numbers since the release of the Senate’s report,” said Resource4thePeople.
“We anticipate that the news of the Yale researchers’ findings will generate even more inquiries from consumers about the legal options they may have to seek compensation and therefore, we will continue to offer free legal consultations and review these claims.”
The Yale researchers were critical of previous Medtronic-funded research studies which provided endorsements of the safety and effectiveness of the Infuse bone grafts. The Yale researchers aid those studies were biased, as did Senate investigators in their report.
The Yale researchers summarized their findings in comparing the Medtronic Infuse bone graft (rhBMP-2) to traditional treatment by saying:
“In conclusion, we found substantial evidence of reporting bias and no evidence that rhBMP-2 is more effective than ICBG in spinal fusion, with some evidence of an association with important harms. More research is needed to provide more reliable estimates of risk for cancer and other adverse events and to identify patient populations in which use of rhBMP-2 may be beneficial, such as cases where use of bone graft alone is associated with a high risk for pseudarthrosis. On the basis of the currently available evidence, it is difficult to identify clear indications for rhBMP-2 in spinal fusion.”
Resource4thePeople said it will also continue to provide regular updates providing consumers who may have been affected by treatment with Medtronic Infuse bone grafts with information about research and legal developments involving the devices.
“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 review claims from 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 warned that 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’s legal team 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.
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 lawsuit raise more questions about the relationships between physicians and Medtronic over fees paid to the doctors that have come under criticism from the 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
For the original version on PRWeb visit: http://www.prweb.com/releases/2013/7/prweb10896169.htm