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From Health Law Daily, April 22, 2015

Split decision saves Medtronic’s Infuse® from additional off-label claims

By Harold M. Bishop, J.D.

In a split decision, the Tenth Circuit Court of Appeals affirmed an Oklahoma district court’s dismissal of a state products liability action brought against Medtronic, Inc. for the off-label promotion of its Infuse® Bone Graft device. The district court held that all of Patricia Caplinger’s state law claims were either insufficiently pleaded or preempted by federal law. The Tenth Circuit found that the claims were preempted (Caplinger v. Medtronic, Inc., April 21, 2015, Gorsuch, N.)

Background. Medtronic, Inc. (Medtronic) produces the Infuse Bone Graft device (Infuse), a device that stimulates bone growth to repair damaged or diseased vertebrae. When it approved the device for sale, the FDA required the company to include a warning label instructing that Infuse should “be implanted via an anterior” surgical approach. The label further cautioned that the device’s “safety and effectiveness . . . in surgical techniques other than anterior open or anterior laparoscopic approaches have not been established” and that “when degenerative disc disease was treated by a posterior lumbar interbody fusion procedure with cylindrical threaded cages, posterior bone formation was observed in some instances.”

Despite this warning, Caplinger alleged that Medtronic and its representatives promoted Infuse for use in a posterior surgical approach, an “off-label” use. Caplinger alleged that a Medtronic representative personally recommended using the device in a posterior approach to her and her doctor. Caplinger also asserted that Medtronic hid evidence documenting dangers associated with posterior surgical approaches. As a result, she and her doctor elected to implant the device using a posterior approach — only to watch complications emerge that could have been avoided had they known the truth. Caplinger alleged that Medtronic’s conduct exposed the company to liability under a variety of state tort theories, including defective design and inadequate warning, breach of warranty, negligent misrepresentation, and negligence.

After the district court held all of Caplinger’s state law claims either insufficiently pleaded or preempted by federal law (see State-law negligence and strict liability claims against Medtronic’s Infuse Bone Graft are preempted by federal law, February 8, 2013), the Tenth Circuit was asked to review the decision.

Analysis. According to the Tenth Circuit, Congress addressed in 21 U.S.C. §360k(a) the extent to which states may layer additional medical device rules on top of Congress’: “No State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement: (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.”

There was no dispute that Infuse endured the FDA’s premarket approval process and that device-specific federal requirements apply to Infuse. Therefore, the question the Tenth Circuit faced was whether 21 U.S.C. §360k(a) foreclosed Caplinger’s state law tort suit against Medtronic.

When it came to her design defect and breach of warranty claims, the Tenth Circuit found that Caplinger did not attempt to identify a single federal statute or regulation that was parallel to her state law claims. However, for her failure to warn, negligence, and negligent misrepresentation claims, it found that she offered candidates for a parallel federal duty: 21 U.S.C. §352 and 21 C.F.R. sec. 801.5. On inspection these regulations, the court found that they did not provide parallels to most of her state claims because they govern only a device’s labeling and her state law claims went well beyond that, attacking not just Infuse’s label, but also Medtronic’s advertising and oral and written representations to her, her doctor, and others. Therefore, as a matter of law, the court found that Caplinger’s state law claims substantially exceeded the potential scope of any federal regulation she identified.

The Tenth Circuit also noted that because Infuse is a prescription device, it wasn’t possible to prepare adequate directions for its safe use by laypeople. For this reason, the court also found that 21 C.F.R. sec. 801.109 generally absolves manufacturers from liability under 21 U.S.C §352 and 21 C.F.R. sec. 801.5, so long as they label their prescription devices in a certain manner approved by the FDA. In addition, once the FDA approves a device’s label as part of the premarket approval process, under 21 U.S.C. §360e(d) the manufacturer may not alter the label’s warnings without prior agency approval.

Caplinger also argued that, even if no parallel federal requirements exist for her state tort claims, her tort claims should have survived preemption because the fact that her suit concerned an off-label use was enough to insulate all her claims from preemption. She argued that because the FDA’s studies and safety assessments generally focus on the device’s intended or on-label uses, it wasn’t appropriate to preempt claims concerning off-label uses. The Tenth Circuit found that textually, section 360k(a) simply did not contain the distinction Caplinger would have it draw between suits addressing on- and off-label uses. Rather, the court found that the statute preempts any effort to use state law to impose a new requirement on a federally-approved medical device.

Caplinger further argued that preemption should occur only when a state requirement differs from or adds to a federal regulation covering the “same subject;” because there are no federal regulations on the “subject” of off-label uses, she reasoned that her off-label claims should not have been preempted. The Tenth Circuit also dismissed this theory because section 360k(a) does not preempt only those state safety requirements addressing the “same subject” as federal requirements. Instead, the statute requires preemption whenever state law is used to impose “any requirement . . . which relates to the safety or effectiveness of the device.”

Dissent. While Circuit Judge Carlos Lucero agreed with most of the majority’s preemption analysis, he wrote separately expressing caution against rushing to preempt state law. Lucero felt that the district court misapprehended law, and he explained why some of Caplinger’s claims were at least plausibly parallel to federal law claims and should have survived a motion to dismiss.

The case is No. 13-6061.

Attorneys: James W. Dobbs (Holladay & Chilton) for Patricia Ellen Caplinger. Murray E. Abowitz (Abowitz, Timberlake, Dahnke & Gisinger, P.C.), Lisa Marie Baird (Reed Smith) and Daniel L. Ring (Mayer Brown) for Medtronic, Inc., Medtronic Sofamor Danek USA, Inc.

Companies: Medtronic, Inc.; Medtronic Sofamor Danek USA, Inc.

MainStory: TopStory PreemptionNews FDCActNews LabelingNews MDeviceNews PLDeviceNews RiskNews SafetyNews ColoradoNews KansasNews NewMexicoNews OklahomaNews UtahNews WyomingNews

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