March 28, 2013: Lawyers for plaintiffs in the Medtronic Infuse Bone Graft litigation believe that injuries received from this product, dating back to as early as 2003, may still be able to file a claim. As with all litigation, the attorneys state that such claims will likely face a vigorous statute of limitations defense but they are working with clients to help protect their potential claims, and anyone who believes they have been injured should seek the advice of competent counsel.
Medtronic Bone Graft Lawsuit Update
The Medtronic Infuse Bone Graft is used during surgery to stimulate bone growth and replace damaged spinal disks. It was marketed and sold as one of the alternatives to harvesting a bone graft from the hip. The Medtronic Infuse Bone Graft is not approved for any other uses but it has been used off-label in cervical spine (neck) procedures.
Medtronic Bone Graft
In 2002 the FDA granted Medtronic approval for its Infuse Bone Graft, but for limited use in the lumbar spine, or lower back, and for some oral and dental procedures. Specifically, the agency approved the Infuse Bone Graft to treat degenerative disc disease and open fractures on the tibia. The FDA also approved Medtronic Infuse Bone Graft for use in sinus augmentation and localized alveolar ridge augmentation.
Medtronic, however, allegedly encouraged physicians to use its Infuse bone stimulator off-label in the cervical spine, which helped generate sales of more than $3 billion for the manufacturer. As of September of 2008, about 680,000 units of Infuse Bone Grafts had been used in the US, according to Medtronic.
The Medtronic bone graft contains recombinant human Bone Morphogenetic Protein (rhBMP), which is a genetically engineered version of a protein that is naturally released by the body. Use of the Bone Morphogenetic Protein initiates bone growth in specific areas of the spine, giving surgeons some control over where the bone re-growth occurs.
The Medtronic Infuse bone growth stimulator in the cervical spine has been associated with many serious problems, including:
Medtronic Complications with Bone Graft Cervical Spine Use
- Difficulty Breathing, Swallowing or Speaking
- Compression of the Airway
- Respiratory Depression
- Nerve Damage
In the wake of at least 38 reports of complications, In July 2008, the FDA issued a warning concerning off-label Medtronic Infuse Bone Graft use, stating that risks were associated with the use of the bone graft on the cervical spine. The agency's warning stated," that the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use.”
FDA Warning on Medtronic Off-Label Use
The reports included patients who experienced difficulty swallowing, breathing and speaking, caused by a "compression of the airway and/or neurological structures in the neck." Many of the patients required emergency treatment, which included tracheotomies, anti-inflammatory medications, feeding tubes and second surgeries.
The Wall Street Journal (09/08/08) reported that FDA records showed approximately 200 adverse events where patients experienced serious complications after the bone graft was used off-label.
According to reports, some doctors who used the bone graft system or who wrote favorable reports about the product may have been paid by Medtronic. The Wall Street Journal also said that Medtronic paid approximately $800,000 over three years to a surgeon who was accused of fabricating a study that reported positive results for the Infuse Bone Graft.
Medtronic Infuse Bone Graft Study Conflict of Interest
The doctor involved, Timothy R. Kuklo, allegedly based the study on "falsified information" and forged the signatures of supposed co-authors. Medtronic said the payments were related to the doctor's work developing products and speaking at company events.
Meanwhile, the FDA was reportedly concerned about Medtronic off-label use of the Infuse Bone Graft before the product was even approved, according to The Wall Street Journal. At the time, Dr. Scott Boden, speaking to an FDA advisory committee, said the discussion of off-label use should not be a focus of the meeting. Dr. Boden allegedly received more than $100,000 a year from Medtronic.
In June 2011, the US Senate Finance Committee announced it is investigating surgeons who were paid consultants for Medtronic. Committee members Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) sent Medtronic a letter to demand that key financial records, communications and documents be turned over to the Committee.
Medtronic Infuse Bone Graft Investigation
The inquiry, which will look into whether those surgeons failed to report complications associated with the Medtronic Infuse Bone Graft, was announced because a soon-to-be-published study suggests that the bone graft product was linked to complications during clinical trials but those complications were not properly reported. Some of those complications reportedly include swelling in the neck and throat, abnormal bone growth and sterility.
In July 2011 The Spine Journal published a number of articles regarding the risks associated with Medtronic’s Infuse Bone Graft, including the following:
- Medtronic’s failure to accurately report the side effects from its clinical trials;
- Medtronic’s failure to report that many of the authors who studied and promoted its product had significant financial ties to the company;
- that Infuse Bone Graft can cause severe problems with nerves and spinal cords;
- and that off-label use of Infuse Bone Graft can lead to severe side effects.
At least three lawsuits were filed against Medtronic by former employees, who alleged the company gave doctors incentives to use Infuse Bone Graft and other Medtronic spine products. Two of the cases were settled without Medtronic admitting wrongdoing.
In December 2008 a Medtronic Infuse wrongful death lawsuit was filed on behalf of a California woman who went into a coma following surgery and died. The lawsuit claimed that Medtronic failed to warn about the risks associated with use of the device in the neck, and that Medtronic actively encouraged off-label uses, none of which have been approved by the FDA.
Another lawsuit claimed that the Medtronic Infuse Bone Graft was used during a cervical spine fusion, which caused the plaintiff severe swelling in the neck and throat. He underwent an emergency tracheotomy.
In July 2011 a California woman filed a lawsuit against Medtronic and Stryker Biotech, both medical device manufacturers, claiming that the companies fraudulently promoted their products for unapproved, off-label use, which was dangerous and resulted in her serious injuries. The plaintiff, 34-year-old April Cabana, was left with nerve compression and severe pain in her lower back and extremities after surgery using a Stryker product. She required a second surgery: her surgeon used Medtronic Infuse Bone Graft in order to fuse the bone, but the product had not been FDA approved for this procedure. According to the lawsuit, Medtronic illegally promoted it for a number of off-label procedures. The surgery made Ms. Cabana’s condition worse.
In September 2011, a Florida woman, Jennifer English, filed a personal injury lawsuit against Medtronic. In August 2007, English was implanted with Medtronic's Infuse Bone Graft during a posterior-approach lumbar spine surgery, which was not FDA approved. The lawsuit claims that Infuse caused her to develop ectopic, or uncontrolled, bone growth in her spine, compressing nerves and leading to chronic and ongoing severe pain. It also alleges that Medtronic fraudulently misrepresented the risks and benefits of Infuse and improperly promoted and marketed Infuse for non-FDA approved uses.
Medtronic Infuse Bone Graft Legal HelpIf you or a loved one has suffered illness, or damages resulting from the use of a Medtronic Infuse Bone Graft, please click the link below to send your complaint to a lawyer to evaluate your claim at no cost or obligation.
Last updated on May-7-15