Preemption Ruling: Federal Appeals Court Strikes Strict Liability and Warranty Claims As to “Off-Label” Use of Bone Graft Device

Last week, the U.S. Court of Appeals for the 10th Circuit in Denver, in a 2-1 decision, upheld a trial court ruling dismissing a complaint on the grounds that federal law preempted a plaintiff’s state law breach of warranty and design defect claims. The claims stem from complications following the alleged “off-label” manner of implantation of a spinal bone graft system. Click here for the opinion in Caplinger.


As the majority explained, under the Food, Drug, and Cosmetics Act, and the Medical Device Amendments thereto, a medical device manufacturer’s products and labeling must receive prior approval. Once approved, changes are not usually permitted without FDA consent.

Although Congress expressly provided for the supremacy of federal law regarding medical devices, 21 U.S.C. §360k(a), legal challenges frequently arise when plaintiffs seek to rely on state regulations. Despite the apparent Congressional intent to broadly preempt state law claims regarding devices, the United States Supreme Court has held that not all claims based on state law are preempted. State regulations that simply “parallel” federal requirements are not preempted. Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996).

The Decision

The product at issue was a device that stimulates bone growth only in the particular area in which the device is implanted. When the FDA approved the device it required the label to advise that only an anterior surgical approach should be used to avoid the complication of unwanted posterior bone growth. Yet, the Caplinger plaintiff alleged that both the manufacturer and its representatives recommended to her and her doctor an “off-label” posterior surgical approach. The device manufacturer moved to dismiss the complaint. Plaintiff sought to show that her state claims only paralleled federal requirements, and that even if they did not, because the device was implanted in an “off-label” manner, preemption should not apply.

The court’s majority opinion disagreed, holding that although state claims that parallel federal requirements are not preempted, the plaintiff failed to identify a single parallel federal or state regulation to support her design defect and breach of warranty claims. After scouring the record, the Court concluded that plaintiff’s claims “substantially exceed the potential scope of any federal regulation [plaintiff] identified.”

As to the claim of off-label use of the device, the majority found that Congress had clearly considered the issue and had adopted a preemption provision that did not distinguish between on- and off-label uses. Thus, the court found it was powerless to supplant the judgment of Congress and the United States Supreme Court that preemption was appropriate in the circumstances presented.


Caplinger represents another key preemption decision with broad implications for medical device manufacturers. The decision makes clear that the preemption defense remains widely viable for medical device makers because Congress’ regulations in this area exhibit its considered belief that additional state law requirements might hinder innovation and postpone patients’ access to important devices without countervailing safety benefits.

Device manufacturers should capitalize on the preemption holding in Caplinger to bring an early end to state law consumer class and other product liability claims.



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