The Philadelphia drug injury lawyers at Feldman & Pinto are evaluating Infuse injury cases from people who have suffered personal injuries from Infuse bone graft systems.
Infuse is a bone graft system made by Medtronic and used in surgeries to fill in spaces that require bone by stimulating bone growth.
While the FDA approved Infuse for certain spinal surgeries, it did not approve it for cervical spine and certain other surgeries. Despite this lack of approval, Medtronic promoted the system for these additional surgeries.
Infuse bone grafting in these unapproved (“off-label”) surgeries is linked to:
- breathing difficulties
- airway compression
- respiratory compression
- nerve damage, and
In July 2008, the FDA issued a warning regarding off label use of Infuse, stating 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.”
The Wall Street Journal has said that Medtronic paid about $800,000 over three years to a surgeon accused of fabricating a study reporting positive results with the Infuse bone graft system. In June 2011, the US Senate Finance Committee announced that it is investigating “payments to surgeons who may have failed to report the complications caused by Infuse.”
Hundreds of plaintiffs have already filed Infuse lawsuits against Medtronic. Infuse lawsuits brought against the manufacturer allege that the company:
- promoted Infuse for unapproved uses
- knew about the risks of serious injury and death associated with the off-label use of Infuse, and
- failed to adequately warn surgeons and the public about these risks
Our Philadelphia Medical Malpractice Attorneys also sue doctors whose negligent care contributed to patients’ Infuse bone graft injuries. A doctor can be liable for a patient’s Infuse injuries if the doctor:
- negligently or knowingly performed an unapproved Infuse bone graft surgery
- negligently performed the Infuse surgery, and / or
- negligently failed to watch for signs and symptoms of complications from Infuse
Contact a Philadelphia Infuse Injury Lawyer
You may be entitled to money damages if you suffered personal injuries from Infuse. Please contact Feldman & Pinto to learn more about filing an Infuse lawsuit. Our personal injury lawyers can help you obtain the compensation and justice you deserve. If you are not certain if a surgeon used the Infuse bone graft system in your surgery, contact your surgeon, the hospital in which the doctor performed the surgery, or your family physician.