California Judge Rejects Medtronic Claim that Infuse Bone Graft Off-Label Marketing Lawsuit is Pre-Empted

A woman who alleges Medtronic Inc. allegedly marketed its Infuse Bone Graft product for off-label uses will be allowed to proceed with her lawsuit.  According to a report from, a California judge rejected Medtronic’s motion for a summary judgment in the Infuse Bone Graft lawsuit, ruling that the plaintiff’s claims were not preempted under federal law.

The plaintiff, whose suit was filed in California Superior Court, Los Angeles County, had received Infuse Bone Graft following an off-label procedure with two products made by Stryker Corp. that resulted in uncontrolled bone growth.  According to her complaint, Infuse did not help her condition, but actually made it worse.  Stryker Corp., the plaintiff’s doctor and a California hospital are also named in the lawsuit, said.

Medtronic had argued in its motion that the plaintiff’s claims were preempted by the U.S. Supreme Court’s Riegel vs. Medtronic decision, which held that state lawsuits involving injuries from medical devices were preempted under federal law if the product was approved by the U.S. Food & Drug Administration (FDA) prior to coming on the market.  But Judge Michael Linfield point out that the Infuse Bone Graft lawsuit was not based on alleged violations of state tort law, but rather claimed that Medtronic illegally promoted off-label use of Infuse in violation of federal law.

Judge Linfield also rejected Medtronic’s argument that the plaintiff’s claims were preempted by another Supreme Court ruling, Buckman Co. v. Plaintiffs’ Legal Committee, which held that allegations that a device maker misrepresented a product to the FDA are a matter for federal court, asserting that the Plaintiff was not making such an allegation.  And he rejected Medtronic’s argument that the plaintiff’s focus on its alleged off-label promotion of Infuse does not protect her claims.

According to Law360, the ruling is believed to be the first to address the federal preemption issue in a lawsuit involving Medtronic’s Infuse Bone Graft product.

Medtronic Infuse is a synthetic form of recombinant human Bone Morphogenetic Protein (rhBMP-2) that is approved for use in one type of spinal surgery and some dental procedures.  In 2008, the FDA issued a safety alert warning that Infuse Bone Graft had been associated with serious complications when used off-label in cervical spine fusions, including excessive swelling in the neck, compressed airways, difficulty breathing, problems swallowing and nerve damage.  It’s been estimated that 85% percent of the procedures that employ Infuse constitute off-label uses of the product

Over the last several years, Medtronic has been embroiled in controversies that have shed doubt on the safety of Infuse, and the company’s marketing of the product.  Among other things, an article published in The Spine Journal last year found that 13 Medtronic-sponsored clinical trials of Infuse failed to report serious complications, including cancer, retrograde ejaculation, sterility in men, infections, bone dissolution and worsened back and leg pain, in patients treated with the product.  The study also raised concerns about the financial ties between Medtronic and the researchers who conducted the 13 studies. Among other things, The Spine Journal prompted a U.S. Senate Committee to launch an investigation of Medtronic’s financial ties to Infuse researchers.  Medtronic has since commissioned researchers at Yale University to conduct an independent review of those 13 trials.

In 2011, another analysis found that the high doses of Infuse that are often needed in off-label procedures could be associated with an increased risk of cancer. In March, Medtronic agreed to pay $85 million to resolve a federal lawsuit brought by shareholders that alleged the company’s officers and executives made false and misleading public statements about Infuse, which then artificially inflated the company’s stock price. The U.S. Justice Department recently closed an investigation of Medtronic’s marketing of Infuse without bringing any charges.

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