At times, we have given a glimpse into the sausage making that goes into our production of posts on recent interesting cases and developments. Part of the process involves standing searches for "published" (including by the electronic services) decisions from trial courts and appellate courts. Sometimes, the trial court decisions are unpublished but interesting, and the appellate decisions are published but not too interesting. When we saw the Sixth Circuit decision in Agee v. Alphatec Spine, Inc., — Fed. Appx. –, 2018 WL 1020078 (6th Cir. Feb. 22, 2018), on one of our standing searches, it was not interesting enough to merit a post. A short per curiam decision noted how awful plaintiffs' complaint was and how they had waived their position on preemption by mixing up express preemption with the implied preemption raised by the defendant's motion to dismiss. We were feeling sleuthy, however, so we tracked down the district court's decision from a year ago. It has a nice discussion of Buckman, and will now be published, so we are going to discuss it.
Agee v. Alphatec Spine, Inc., No. 1:15-cv-750, 2017 WL 5706002 (S.D. Ohio. Mar. 27, 2017), reads like the sort of case brought when the plaintiffs are looking for someone on whom to pin liability in the absence of a claim against the most logical defendant. The plaintiffs claimed that a surgeon used defendant's product in connect with unnecessary spinal surgeries without proper informed consent, but the surgeon fled the country with criminal charges pending. So, the plaintiffs asserted various product liability claims against the manufacturers of the product, PureGen. Usually, we would state clearly what type of product is at issue, but neither decision really says, other than to say the defendants are medical device companies and the product was used to stimulate bone growth. We did a little looking and saw that PureGen is an "osteoprogenitor cell allograft" derived from donated adult stem cells. We also saw that there was some history with FDA over whether this was a biologic, requiring approval of a Biologics License Application, or a device that might go through the 510(k) pathway. In any event, plaintiffs seemed to claim defendants should be liable for their injuries—it was unclear that there were any physical injuries—solely because PureGen "had never been approved by FDA for use in the spine." Defendants moved to dismiss.
We will skip over the TwIqbal part of this—although there are nice statements and the interesting fact that some of the plaintiffs were suing in the same court with contrary allegations about another product—and the some of the details of Ohio law to get to the Buckman part. After reiterating the Buckman standard and the cases explaining that a court is to look at the asserted claims to see if a violation of the FDCA is a critical element, the court did just that, providing something of a roadmap on what is preempted under Buckman. The claim for defective manufacturing alleged that the failure to obtain FDA approval made the product produce injury. (That is not close to a manufacturing defect claim under Ohio law, which has codified the claim under ORC 2307.74.) The design defect claim was identical (and similarly off-target from ORC 2307.75). The warning defect claim was also predicated on lack of approval of the product, but not even that the warning misrepresented the regulatory status. The misrepresentation claim was predicated on a representation to plaintiffs and their doctors that the product was approved or concealing from them that it was not. A similar claim for nonconformance with representation (under ORC 2307.77) was slightly less clear, in that it referenced "representations made by defendants concerning the product and/or with applicable federal requirements."
The court's analysis of these claims was clear and quotable:
Each of the above-quoted claims is clearly dependent upon the FDCA to a degree that the claims would not exist but for the statute. It may or may not be the case that the promotion and distribution of PureGen for use in the surgeries references in the complaint was in violation of the FDCA and relevant FDA regulations. However, if that is the case, it is the sole responsibility and privilege of the federal government, and not private plaintiffs, to bring a suit to enforce those violations.
Well-reasoned. And dispositive. And now affirmed on appeal.
This article is presented for informational purposes only and is not intended to constitute legal advice.
