Supreme Court preemption doctrine leaves only a narrow sliver of claims available to plaintiffs who claim to have been injured by a Class III medical device. (For a more detailed discussion of the application and intersection of express preemption and implied preemption in the medical device context, see our earlier post.) As a result, plaintiffs in medical device product liability cases are constantly searching for ways to craft their pleadings to attempt to avoid dismissal on preemption grounds. Some plaintiffs include in their complaints allegations of off-label promotion by the device manufacturer. In the case of Caplinger v. Medtronic, Case No. 5:12-cv-630 (W.D. Okla. Feb. 6, 2013), the district court recently ruled that allegations of off-label promotion do not save medical device claims from preemption.
In Caplinger, the plaintiff claimed that she was injured by the defendants’ Infuse bone graft device, which her doctor used while performing posterior lumbar fusion surgery. Id. at 1. A Class III medical device, the Infuse graft was approved by the FDA through the Premarket Approval (“PMA”) process for use in anterior lumbar fusion surgery, which is performed through the abdomen, but not for posterior lumbar fusion surgery like the plaintiff’s, which is performed through the back. Id. at 2. The plaintiff’s complaint asserted various causes of action against the device manufacturer sounding in strict liability, negligence, breach of warranty, and fraud.
In dismissing all of the claims as preempted, the court discussed the interplay between express preemption under Riegel v. Medtronic, 552 U.S. 312 (2008), and implied preemption under Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001): “Riegel and Buckman create a narrow gap through which a plaintiff’s state-law claim must fit if it is to escape express or implied preemption. The plaintiff must be suing for conduct that violates the FDCA…, but the plaintiff must not be suing because the conduct violates the FDCA.” Id. at 10 (quoting Riley v. Cordis Corp., 625 F. Supp. 2d 769, 776-77 (D. Minn. 2009)) (emphasis in original). Thus, the accused conduct must not only violate the FDCA, it must give rise to a state law claim independent of the FDCA. Id. The court further noted the Supreme Court’s recognition that “off-label use is not illegal or even disfavored under federal law but is an accepted and valuable part of the practice of medicine.” Id. at 16 n.3.
The court categorically rejected the plaintiff’s argument that express preemption does not apply to claims involving off-label promotion, explaining that nothing in the statute suggests that preemption depends on how the device is used or “how the device is being promoted to be used.” See id. at 16-17.
The plaintiff also argued that the off-label promotion allegations in her complaint constitute “parallel claims” which are not preempted because “defendants’ failure to obtain approval for posterior use of the Infuse Device, their intentional off-label promotion of the Infuse Device, and their failure to provide adequate warnings for the off-label/unapproved uses” violated federal law and subjected the defendants to state tort liability. Id. at 14-15. In rejecting this argument, court explained that “the federal requirement that manufacturers not promote devices for off-label uses is not genuinely equivalent to the state law requirements that a manufacturer provide adequate warnings to physicians about the risks of its medical device and that a manufacturer not produce a product with a defective design.” Id. at 17 n.4.
The court then analyzed the plaintiff’s claims one-by-one, finding them all expressly preempted because they called for a jury to second-guess the FDA-approved design, manufacturing, labeling, warning, and/or marketing requirements for the device. Moreover, to the extent the claims were premised on allegations of off-label promotion they were also impliedly preempted because the prohibition against off-label promotion is a creature of federal regulation with no independent basis in Oklahoma tort law.
Finally, the court rejected the plaintiff’s argument that the defendants’ motion to dismiss was premature as she had not been permitted to conduct discovery regarding the defendants’ off-label promotion efforts. As preemption is a matter of law, no discovery is necessary; the defendants’ motion to dismiss was ripe for adjudication.