S.J. Quinney College of Law

by Shaun Mather

Judge G. Murray Snow of the U.S. District Court for the District of Arizona recently gave plaintiffs in medical device suits a mechanism to avoid preemption of their state tort claims. Under the Supreme Court’s decision in Riegel v. Medtronic, Incorporated,[1] the preemption clause of the Medical Device Amendments of 1976[2] preempts state tort claims arising out of a physician’s “off-label” use of a medical device.[3] However, Judge Snow ruled in Ramirez v. Medtronic Inc.[4] that medical device maker Medtronic Inc. could not benefit from the Supreme Court’s preemption doctrine.[5] Judge Snow premised his decision on the fact that Medtronic actively promoted off-label use of its medical device.[6]

Ramirez arose when Cristina Ramirez’s (“Ramirez”) surgeon, Dr. Wang, performed a lumbar fusion procedure on Ramirez to alleviate her back pain.[7] Dr. Wang used Infuse, a “bio-engineered liquid bone graft substitute,” to perform the procedure.[8] Infuse is manufactured by Medtronic and is a Class III device under the Medical Device Amendments of 1976 (“MDA”).[9] A Class III device is subject to the “highest level of regulatory scrutiny” before the manufacturer may market the device.[10] The scrutiny occurs when the manufacturer submits the device to the FDA for a Premarket Approval Application (“PMA”).[11] The manufacturer must disclose the device’s intended use before submitting the device for a PMA.[12]

Medtronic intended physicians to use Infuse for “single-level anterior lumbar interbody fusion” operations, which are “performed with all three [of Infuse’s] components in a specific spinal region.”[13] The FDA did not approve Infuse for any other use.[14] However, the MDA expressly permits physicians to use FDA-approved devices “off-label,” or in a manner not approved by the FDA.[15] Dr. Wang used an un-approved posterior approach on Ramirez,[16] which caused Ramirez to develop uncontrolled bone growth in the region Dr. Wang implanted the device.[17] Because of the MDA’s preemption clause and the Court’s ruling in Riegel, Dr. Wang’s off-label use by itself did not create liability for Medtronic.

However, Medtronic promoted these off-label uses by establishing consulting and royalty agreements with physicians who advocated off-label uses to other physicians.[18] The Food, Drug, & Cosmetic Act (“FDCA”) prohibits a manufacturer from promoting an unintended use of its device.[19] In other words, a manufacturer’s off-label promotion violates federal law.[20] If a manufacturer wishes to alter the device’s labeling or intended use, the manufacturer must follow the supplemental PMA procedures established by the FDA.[21] Medtronic did not follow those procedures.[22]

 Premised on Medtronic’s promotion of off-label use, Ramirez asserted six state law causes of action: fraudulent misrepresentation, failure to warn, defective design, misrepresentation, negligence, and breach of express warranty.[23] Medtronic moved to dismiss Ramirez’s complaint, arguing the MDA and FDCA preempt Ramirez’s state common law claims.[24]

The MDA preemption clause states:

Except as provided in subsection (b) of this section, 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.[25]

The preemption clause protects medical device manufacturers as long as they comply with the federal requirements and preempts any state requirements that are “different from, or in addition to, any requirement applicable . . . to the device” under federal law.[26] Common law causes of action are state “requirements” for purposes of the preemption clause because “they impose standards of conduct on manufacturers that could potentially differ from those set by the FDA.”[27] However, the preemption clause does not prevent a state court from providing damages for claims premised on a violation of FDA regulations where the state duties and requirements “parallel,” rather than add to, the federal requirements.[28] This is not true if the state requirements are different from, or in addition to, the federal requirements. Accordingly, the preemption clause does not preempt parallel claims.[29]

Before Ramirez, district courts considering the question held that off-label promotion by manufacturers were not parallel claims; thus, the state claims were subject to preemption. For example, in Caplinger v. Medtronic, Inc., the United States District Court for the Western District of Oklahoma held the plaintiff’s allegations of Medtronic’s promotion of off-label use in violation of federal law did not “automatically immunize” a plaintiff’s state claims from preemption.[30] The court also found that allegations of off-label promotion did not turn the plaintiff’s state claims into “parallel” claims that are not preempted.[31]

However, Judge Snow reasoned that those courts failed to recognize the manufacturers established a new and unregulated use by promoting off-label use.[32] No federal determinations conflict with a state jury verdict regarding the safety or adequacy of the medical device because the FDA has not approved the off-label uses.[33] Therefore, Judge Snow held the parallel claim analytic is inapplicable to claims arising out of a manufacturer’s promotion of off-label use.[34] 

The preemption clause did not preempt Ramirez’s state claims against Medtronic because Ramirez did not need to establish her state law claims paralleled the federal requirements.[35] Ramirez’s state claims did not require Medtronic to do anything “different from, or in addition to” the federal requirements because the FDA had not reviewed the off-label uses. There would be no conflict between a state jury verdict and the FDA’s regulatory scheme; thus, there was no reason to preempt Ramirez’s state law claims.[36] Medtronic made itself amenable to state law claims by sidestepping the FDA’s supplemental PMA process and promoting the off-label use.[37]

 In sum, if other courts follow Judge Snow’s reasoning, plaintiffs filing state claims premised on a medical device manufacturer’s promotion of off-label use will have won a victory. However, whether future courts will side with Judge Snow instead of courts like the Caplinger court is yet to be determined.

Shaun Mather, a 2L at the University of Utah S.J. Quinney College of Law, is a Fellow with the Center for Law and Biomedical Sciences.

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