An Oregon man has filed a product lawsuit against Medtronic over its Infuse bone graft product, alleging that the company promoted it for “off-label” uses, which caused severe complications when the bone growth agent was used without the approved LT-Cage.
The complaint (PDF) was filed by Richard D. Alton, in the U.S. District Court for the District of Oregon.
Alton was implanted with the bone growth stimulant in April 2010. However, it was used without an LT-Cage, which is used in most BMP bone graft surgeries to help guide bone growth.
The surgeon has indicated the off-label surgery was performed because the manufacturer failed to provide adequate information about the risk of problems with use of Medtronic Infuse without the LT-Cage.
According to allegations raised in the Medtronic Infuse lawsuit, the lack of the LT-Cage and use of the bone growth agent during a posterior approach to spinal fusion surgery caused excessive bone growth around the spine.
Following the surgery, Alton suffered severe pain in his lower back, which spread down his right leg to his right foot. Alton alleges that he has been left with constant pain that limits his everyday activities. His doctor is not certain that revision surgery will help.
Metronic Infuse BMP Off-Label Use
Medtronic Infuse is a bone morphogenetic protein (BMP) that is applied to an absorbable collagen sponge placed within a device known as an LT-Cage, which is then implanted to encourage bone growth and fuse the gaps between vertebrae.
Although the FDA only approved the Medtronic Infuse and LT-Cage for the limited spinal procedures involving a single-level anterior lumbar interbody fusion (ALIF), where the spine is approached from the front, the Medtronic Infuse has been widely used “off-label” for other types of spine fusion surgery, which have been linked to an increased risk of severe and painful complications caused by excessive or ectopic bone growth.
The lawsuit claims that it was Medtronic’s illegal promotion of Infuse for uses not approved by the FDA, known as “off-label” use, that led to Alton’s doctor implanting the Infuse without the LT-Cage. Alton’s doctor noted that the literature available at the time of Alton’s surgery suggested that Infuse was safe and effective. It was only after the surgery that new data was released suggesting that ectopic bone growth was a problem. His doctor lodged a complaint with Medtronic.
The allegations are not new. Investigations by the government have uncovered evidence that Medtronic intentionally mislead the medical community about the safety of Infuse.
Last year, a congressional investigation determined that Medtronic paid $210 million to study authors that failed to include data on Infuse complications in their reports. Those authors not only failed to disclose links to Medtronic, but the investigation also determined that Medtronic employees secretly edited and sometimes wrote parts of the studies before they were published.
Mounting Medtronic Infuse Lawsuits
Alton’s complaint joins a growing number of lawsuits over use of Medtronic Infuse that have been filed in state and federal courts throughout the country.
The plaintiffs allege that when the FDA approved the use of Infuse, it specifically stated that the Infuse and the LT-Cage must be used together as a system, and that the Infuse must not be used without the LT-Cage. However, Medtronic sells Infuse separately from the LT-Cage. The FDA specifically warned Medtronic not to promote the use of the Infuse off-label due to the risk of harm to patients, however, Medtronic allegedly paid spine surgery “opinion leaders” in the medical community to do just that.
Off-label use has accounted for the majority of Medtronic Infuse sales.
In 2008, the FDA issued an alert about the risks associated with such unapproved uses of Medtronic Infuse, after receiving a number of reports involving serious complications and deaths, often involving use in the cervical spine where the bone growth problems may impact the airway.
Alton’s lawsuit charges Medtronic with fraudulent misrepresentation, failure to warn, defective design, negligence, and breach of warranty. The lawsuit seeks compensatory and punitive damages.