In June of 2012, Stryker initiated a voluntary recall of its Rejuvenate and ABG II modular-neck hip stems due to the potential for fretting and corrosion at the modular-neck junction. This defect can result in various adverse local tissue reactions, as well as pain, swelling, limitation on range of motion, and premature device failure.
The inspector general for the Health and Human Services Department has issued a “special fraud alert” notice regarding physician-owned distributorships of medical devices that profit from selling their implantable medical devices for use in procedures performed by their physician-owners on their own patients.
The Food and Drug Administration (FDA) issued a Class I Recall for LPS Diaphyseal Sleeves, commonly used in knee replacement surgeries, on February 15, 2013. A Class I Recall is the most severe recall issued by the FDA, indicating the potential for serious injury or death.
March 3, 2013 – Los Angeles jurors voted today to award $8.3 million to Mr. Loren “Bill” Kransky, a Montana man injured by a faulty DePuy hip replacement part. The man reportedly received his hip implant, a metal on metal unit, in 2007. Kransky suffered numerous health consequences as a result of particulates shaving off of the replacement part during times of movement and flowing into the bloodstream. As a result, patients like Kransky have as much as 16 times the allowable levels of both cobalt and chromium in their bloodstreams. Heavy metal poisoning, damage to internal organs and more were reportedly caused by the DePuy hip implant.
In an effort to maximize the efficiency of pre-trial efforts in multiple counties, the New Jersey Supreme Court has ruled that Rejuvenate Hip Stem and ABG II Modular Hip Stem lawsuits throughout the state be centralized into a “Multicounty litigation.” According to court documents, consolidated pre-trial proceedings will go before Bergen County Superior Court Judge Brian R. Martinotti, the same judge currently handling the Depuy ASR hip implant multicounty litigation. Keefe Bartels has been designated co-lead counsel of the Depuy litigation.
Highly positive studies published in peer-reviewed medical journals depicted Medtronic's spine fusion product as a major breakthrough in back surgery, but those studies drafted and edited with direct input from company employees, while the doctors listed as authors were paid millions, according to a U.S. Senate investigation.
The company's heavy, undisclosed manipulation of information about its bone morphogenetic protein-2 product called Infuse included removing and downplaying concerns about serious complications linked to the product and overstating its benefits.
On August 10, 2012, Keefe Bartels informed hip implant patients of the massive recall by Johnson & Johnson’s Depuy Orthopaedics subsidiary of over 93,000 units of its ASR all-metal artificial hip implant device.
Keefe Bartels previously informed implant patients of the dangerously high failure rate of metal-on-metal artificial hips. Today, more disconcerting news confirms the serious risks and harms associated with these types of medical devices. Smith & Nephew issued a recall of the component parts used (either a metal liner or cup) in its R3 Acetabular System in artificial hip implant. [See photo of component part of R3 Acetabular System - http://global.smith-nephew.com/us/R3_Acetabular_System_24410.htm]
As the problems with metal on metal hip implants become more widely recognized, patients and doctors are starting to question the lack of testing and regulatory oversight surrounding the medical device industry. Most medical devices are approved by the FDA and sold to patients despite having undergone little or no testing to determine if the devices are safe, or if they even work. The inevitable result of such an abject failure on the part of the FDA and the manufacturers themselves is becoming increasingly clear. Devices that are not safe are nevertheless being sold and implanted into unsuspecting patients, who are in effect being used as guinea pigs by the medical device industry.
The Medtronic Infuse Bone Graft
is a bone filling material that contains a bone protein which stimulates bone growth and can be used to repair damaged spinal vertebrae. The Infuse Bone Graft consists of genetically recombinant human Bone Morphogenetic Protein (rhBMP-2) which is similar to the actual bone growth protein found in the human body. This eliminates the task of taking or grafting a bone from the hip or other areas and the patients can avoid excessive pain and lengthy recovery periods.
The US Food and Drug Administration's approval
of Medtronic's Infuse bone stimulator was only for use in spinal fusion surgeries of the lumbar spine or lower back and certain oral and dental procedures. However, it has been used for unapproved or off-label purposes based on surgeon's discretion. It is estimated that 85% of the uses of Infuse are off-label.
Safety Issues Involving the Medtronic Infuse Bone Graft Come to Light
Dr. Eugene Carragee, a Stanford University School of Medicine professor and editor-in-chief of the Spine Journal, recently pointed to evidence that some patients using the Infuse Bone Graft suffered serious health complications such as cancers (pancreatic, prostate and breast), infections, sterility in men, bone disintegration, and severe back and leg pain. In his interview to Reuters
, Dr. Carragee discussed his findings that showed BMP in Infuse leads to 2.5 times greater risk of developing cancer one year after it is used and five times increased risk after three years.
The US Senate and the Department of Justice has also raised concerns regarding the negative side effects of using Medtronic Infuse Bone Graft for spine surgery. According to the Senate Finance Committee
, the clinical trails conducted by Medtronic to test the safety and effectiveness of Infuse did not report any medial complications as a result of product usage. The Medtronic-funded internal study stated that the bone growth as a result of Infuse did not have any harmful effect on the patients. This was refuted by a comprehensive study that showed neurological impairment and other complications associated with irregular bone growth caused by the Infuse Bone Graft.
The Senate Finance Committee
also highlighted in their letter to Medtronic that one of the authors of the now debunked clinical trials received royalty payments from Medtronic in excess of several million dollars. That trial failed to report Infuse's link to higher rates of temporary or permanent sterility in men.
Medtronic Infuse Bone Graft Lawsuits
The use of Medtronic Infuse Bone Graft in the cervical spine has resulted in serious problems. Keefe Bartels is currently screening for cases in which a patient has used the Medtronic Infuse Bone Graft and later suffered any of the following:
Hypertrophic Bone Growth, and other abnormal growth problems
If you or your family members have undergone cervical spine fusion or neck surgery and been treated with Medtronic Infuse Bone Graft, contact our competent lawyers at Keefe Bartels for a thorough evaluation on your case. All consultations are free of charge.