San Diego, CA (PRWEB) April 21, 2013
Resource4thePeople announced today that it is providing consumers an update of the legal proceedings involving allegations that the Medtronic Infuse Bone Grafts may have caused serious, life-threatening health problems.
In one of the most recent legal actions, a federal lawsuit* has been filed 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 lawsuits claim that "medically unnecessary, experimental spine surgeries" were performed "using falsely and improperly market4ed Medtronic medical devices and drugs," according to allegations contained in the court file.
Resource4thePeople said that its national network of attorneys are also accepting cases from consumers who allegedly may have suffered serious health problems as a result of Medtronic Infuse bone graft surgeries.
“We are now reviewing these claims as a result of the increasing number of inquiries from consumers about their legal rights to seek compensation in connection with alleged serious health side effects such as severe back and leg pain, infections, bone deterioration, sterility and cancer,” said Resource4thePeople.
Resource4thePeople also said that the allegations filed in the new lawsuits 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.
“After announcing that free legal consultations will be provided to consumers who are inquiring about alleged Medtronic Infuse bone graft side effects we observed that a large number of these consumers contacted us after reading the findings of the committee," said Resource4thePeople.
“The revelations included in the recently released 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."
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.
One such article was published by Reuters News Service in which the report said:***
“There were questionable ties between Medtronic and physician consultants who tested and reviewed the company's product, the U.S. Senate Finance Committee said in the report, which concludes a 16-month investigation covering 5,000 documents relating to 13 studies of Infuse.
“Medtronic paid about $210 million in royalties and consulting fees to the authors of company-sponsored studies between November 1996 and December 2010, the report said.
“Those sponsored studies failed to mention complications from the product, including male sterility, an increased risk of cancer, infections, bone dissolution and worsened back and leg pain.”
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.
Resource4thePeople said that its lawyers are investigating claims from patients who are complaining about such serious health problems as severe back and leg pain, infections, bone deterioration, sterility and cancer.
These cases primarily involve situations in which the Infuse was used in what is called an off-label use, such as to the neck area. Victims of these side effects will be informed about the possibility of compensation for pain and suffering, loss of wages, medical costs and other expenses associated with the surgeries.
“Resource4thePeople is shocked by the findings of the Senate Finance Committee which, in very strongly worded language, said that Medtronic essentially attempted to sway public opinion about the safety of their product by paying millions of dollars to doctors and researchers to write positive reviews,” the organization said in announcing the legal referrals.
“When a bipartisan committee issues such a report it obviously shows the strong feelings that our elected officials have about a medical device company shielding negative facts about the safety of their product from consumers while paying to have positive information circulated in respected medical journals.”
Resource4thePeople also is recommending that any patient who had a Medtronic Infuse bone graft take the time to read the report that was issued jointly by Committee Chairman Max Baucus (D-Mont.) and senior member Chuck Grassley (R-Iowa) after the 16-month investigation into Medtronic revealed questionable ties between the medical technology and medical research findings.
“Medtronic’s actions violate the trust patients have in their medical care. Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has,” Senator Baucus said. “Patients everywhere will be better served by a more open, honest system without this kind of collusion.”
“These findings emphasize the value of the Grassley-Kohl Physician Payments Sunshine Act, which will result in public disclosure of industry payments to physicians starting next year. The findings also should prompt medical journals to take a very proactive approach to accounting for the content of the articles along with the authorship of the articles and studies they feature,” Grassley said.
“Resource4thePeople also notes that there have long been concerns about the safety of the cervical spine fusions and that FDA issued a Public Health Notification in 2008 warning about life-threatening complications associated with recombinant human bone morphogenetic protein in cervical spine fusion.****
*Case # 1:13cv0202 U.S. District Court, Southern District of Ohio