Personalized medicine is the wave of the future. Whether treating disease or prescribing medical devices (or both), medical practitioners are taking individualized patient characteristics into account more and more as they treat their patients. Cancer therapy can now be targeted at the genetic level, and some medical devices can now be created to match patient imaging and other custom input. The objective, of course, is better patient outcomes, but as defense lawyers we have wondered aloud multiple times what this all could mean for product liability when outcomes are not all rosy. We wrote just a few weeks ago on how personalized medicine could impact duties to warn on genetic variations. We mused on 3D printing for the first time more than eight years ago. And we have gone back to that well multiple times over the years (here and here, for example), each time identifying potential issues and pitfalls. Heck, Bexis and our colleague Matthew Jacobson even wrote a law review article on the topic a few years back.
This is the backdrop against which we viewed a recent Nevada case reinstating product liability claims against dentists who allegedly designed, manufactured, and surgically implanted custom dental implants. The case is Estate of John Cronin v. G4 Dental Enterprises, No. 84075, 2023 WL 2779206 (Nev. Ct. App. Apr. 4, 2023), and while the opinion does not disclose whether the implants were 3D printed, the opinion raises all the same questions. The patient sadly passed away after having 23 teeth removed and replaced (for those keeping score, that is more than two-thirds of a normal human complement of teeth), and his family sued for medical malpractice and product liability. Id. at *1. The Nevada Court of Appeals held that they could sue for both.
This is not your garden-variety medical device, product liability case. The plaintiffs alleged that the dental implants were both a procedure and a product. One of the dentists performed the surgery (the “procedure”), and he also allegedly invented a proprietary process involving the design and in-house engineering of the custom implants (the “product”). He allegedly was the exclusive provider. Id. at *7. In other words (and in the language of product liability), the dentist “designed the implant, and manufactured and sold it to customers.” Id. at *9. From there, the Nevada court had no difficulty holding that the trial court should not have dismissed the plaintiffs’ product liability claims.
We will see how the plaintiffs’ hybrid med mal/product liability lawsuit goes on remand. But, in the larger scheme, we can foresee multiple issues that lawsuits like this will raise. Courts have long seen healthcare providers as service providers to whom product liability law does not apply. The introduction of in-house fabrication (known as “point-of-care” manufacturing) surely blurs the lines.
We also need to revisit our prior discussions of the regulation of 3D-printed devices (again, we can’t tell whether the dental implants in this Nevada case were 3d printed, but still). The FDA regulates medical devices, including 3d-printed medical devices when made by medical device manufacturers (see here for more information). But point-of-care devices appear to still be a matter of regulatory discussion. Who then are the relevant regulators for providers like our Nevada dentists? The FDA, or state-level regulatory commissions, or plaintiffs’ attorneys applying tort law, or all of the above? If FDA regulation applies (and maybe it does not if the subject devices did not cross state lines), providers may be subject to FDA’s Good Manufacturing Practices, which may (or may not) impact the applicable standards of care. That would be especially true in states where regulatory compliance is a defense or partial defense.
We wonder whether strict product liability should apply to devices designed and manufactured by healthcare providers. Strict product liability is justified in part by a manufacturer or seller’s ability to spread the cost of risk over multiple users. Moreover, in the case of unavoidably unsafe products (which includes all drugs and medical devices), strict liability is balanced by the obligation to provide warnings on known and knowable risks. These paradigms are difficult to apply to healthcare providers, who operate under a different warnings regime that focused on informed consent.
Which leads us to the learned intermediary doctrine, which holds in most every state that a prescription product manufacturer’s duty to warn runs to the prescribing healthcare provider (the learned intermediary), and not directly to the patient. It makes perfect sense, unless the manufacturer and the provider are the same. There is no intermediary! (Pause here while your DDL bloggers recover from fainting.) So maybe the manufacturer’s duty to warn and the physician’s duty to obtain informed consent merge. Try instructing a jury on how that ought to work.
Finally, we would not be the Drug and Device Law Blog if we did not mention federal preemption. We are unaware of any point-of-care device approved under the FDA’s rigorous Premarket Approval process. But if there are any—now or in the future—express preemption under the Medical Device Amendments should apply. Implied preemption should be on the table, too. How odd that will be when a healthcare provider asserts federal preemption as a complete defense.
While this largely an issue-spotting exercise for us, the dental implant litigants in Nevada will have to proceed on remand for real. We wish both sides the best of luck, and hopefully we have not heard the last of their case.