Most Claims in Infuse Bone Graft Lawsuit Not Preempted, Rules Federal Judge

An Arizona judge has ruled that state-level claims accusing Medtronic of improperly promoting off-label use of their Infuse bone graft product are not preempted and stand independently of federal law. On August 21, Judge G. Murray Snow issued an order explaining that when a medical manufacturer is promoting off-label use of a product or medication, there is no policy basis on which to preempt the application of state law.

The ruling comes more than four years after the plaintiff in question first received Infuse – a bio-engineered liquid bone graft substitute – as part of treatment for back pain. According to the Infuse bone graft lawsuit she filed earlier this year, the woman experienced severe pain after the surgery, and it was discovered that she was developing uncontrolled bone growth in the surgical area. She sued Medtronic for failure to warn, defective design, misrepresentation and negligence, basing her claims on the surgeon’s off-label application of the device. The surgeon allegedly opted for off-label use based on Medtronic’s active promotion of that use.

The FDA originally approved Infuse for use during a single-level anterior lumbar interbody fusion (ALIF), a procedure in which incisions are made from the front of the body. But it has increasingly been used by doctors for other types of spine fusion surgery such as the operation undergone by the Arizona plaintiff.

Infuse bone graft lawsuit involves off-label use

Medtronic had filed a motion to dismiss the Infuse bone graft lawsuit on the grounds that such claims are federally preempted by a law stating that individual states are prohibited from imposing “any requirement which is different from, or in addition to, any requirement which relates to the safety or effectiveness of a Class III Pre-Market Approved medical device intended for human use.”

Judge Snow explained how state law was not preempted by federal regulations:

“When a plaintiff is injured because her doctor used an FDA-approved device for an unapproved use, and she brings state law tort claims against the manufacturer claiming that it should have provided additional warnings or designed the product differently in light of this unapproved use, the plaintiff is asking the manufacturer to do something ‘different from, or in addition to’ federal law.”

Because the plaintiff’s alleges she was injured because of an off-label application of Infuse resulting from the manufacturer’s promotion of such use, the Judge concluded that most of the claims made in her Infuse bone graft lawsuit are exempt from preemption:

“When the device is not being used in the manner the FDA pre-approved and the manufacturer is actually promoting such use, there is no law or policy basis on which to preempt the application of state law designed to provide that protection… when Medtronic allegedly violated federal law by engaging in off-label promotion that damaged the Plaintiff and thereby misbranded the Infuse device, it departed the realm of federal regulation and returned to the area of traditional state law remedies,” the Judge said.

Medtronic Infuse litigation can proceed

Judge Snow went on to address the specific counts filed in the Infuse bone graft lawsuit. He ruled that the plaintiff’s claims of fraud still stands, as do the claims of failure-to-warn and misrepresentation. He explained, “Medtronic changed the calculus when it began promoting Infuse for a use that differed from the approved uses.”

Similarly, the plaintiff’s design defect allegation is not preempted because she alleged that Medtronic actively promoted the off-label use of Infuse. However, the negligence claim is as it is based entirely on federal violations.

The lawsuit is just one of dozens that allege severe and debilitating Infuse bone graft complications, such as ectopic bone formation, infection, nerve damage, tissue degeneration and cancer.