Latest Medtronic Infuse Bone Graft Failure Allegation Lawsuits Update: Resource4thePeople Praises Newspaper Editorial Citing “Rigged Medical Research” in Connection with Devices
Chicago Tribune article follows up on Yale University study that found 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 29, 2013
Resource4thePeople, in its latest update to consumers following the progress of lawsuits over Medtronic Infuse bone graft failure allegations, announced today its support of an editorial on the product by a respected newspaper.
The Chicago Tribune on July 6, 2013 ran an editorial* "The danger of rigged medical research" that detailed concerns about the reliability of Medtronic's products and marketing.
"Resource4thePeople is encouraged that a respected newspaper would issue such a damning editorial about the Medtronic Infuse bone graft because we have been receiving increasing numbers of allegations from consumers about serious health problems attributed to this product.
"We will continually support all efforts by the major media to shine a light on issues such as this that also have come under the scrutiny of the Food and Drug Administration and U.S. Senate in the interests of consumer safety."
As the paper editorialized:
"Yet doubts persisted about the value of Infuse, and now those doubts have been confirmed by independent reviewers. In many cases Infuse provides little or no increased benefit compared to the traditional method of bone grafting. In some cases, it poses a greater hazard. The research that had so strongly supported the use of Infuse was found to be biased in favor of the manufacturer, Medtronic Inc."
The editorial was a follow-up on the findings of a two-year study by Yale University researchers over concerns about the marketing and safety of Medtronic Infuse bone grafts similar to those included in allegations now being reviewed by Resource4thePeople attorneys.
"Our nationwide network of attorneys is continuing to offer free consultations to consumer seeking information about legal options they may have over allegations of serious health problems as a result of Medtronic Infuse bone grafts," said Resource4thePeople.
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.
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 said 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 also is announcing that it will continue to provide regular updates for consumers who may have been affected by treatment with Medtronic Infuse bone grafts.
“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.”
Resource4thePeople also said that its 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.
*****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/prweb10962268.htm