Just two weeks before the U.S. Supreme Court decided Riegel v. Medtronic, the Supreme Court of Arkansas had decided Despain v. Bradburn, No. 07-714, 2008 WL 324356 (S. Ct. Ark. Feb. 7, 2008). We dutifully reported that case in our Device Preemption Scorecard, but otherwise didn’t say much about it, because we’re upbeat guys and don’t like to wallow in bad news.
In Despain, a physician had implanted a Soundtec hearing device in plaintiff. The FDA had approved the device through the premarket approval (or PMA) process. Plaintiff pleaded that he suffered damage to his ear as a result of interference between the magnet in his hearing device and electronic welding equipment used in the plant where he worked. Plaintiff pleaded the usual strict liability, negligence, and warranty claims, as well as malpractice claims against Dr. Bradburn, the treating physician.
The trial court granted summary judgment in Soundtec’s favor based on both preemption and the learned intermediary doctrine. A jury later returned a defense verdict in the trial against the treating physician.
Before Riegel came down, Despain was decidedly not a good case for defendants. It rejected PMA preemption on two different grounds: First, strict liability, negligence, and warranty claims supposedly did not impose requirements compelling “a specific change in the way the hearing device was manufactured.” Second, “even if a state common-law tort claim did constitute a device-specific requirement that was subject to preemption by the [Medical Device Amendments], the lack of device-specific federal regulation from the FDA applicable to the hearing device at issue would still render federal preemption inapplicable.”
Two weeks ago, those were not helpful words for defendants. But Riegel erases all of the bad stuff. Riegel squarely holds that state common law tort claims impose requirements that can be preempted by federal law, and the PMA process imposes device-specific requirements that have preemptive effect.
Voila! The bad stuff out of the Arkansas Supreme Court is gone!
But keep on reading. The Arkansas Supreme Court based its anti-preemption result in part by analogizing to an earlier Arkansas precedent involving the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Despain held that the preemption clause in FIFRA “is very similar to the language of the” Medical Device Amendments. (The concurrence in Despain also analogized to FIFRA, citing a Montana Supreme Court case that held that the word “requirements” in a federal preemption statute applies only to enactments of positive law by legislative or
administrative bodies and not to state law damages actions.)
Back when we were on the losing end of this argument, we didn’t much like that FIFRA analogy.
Now that we’re on the winning side, we’re changing our mind. If the Arkansas Supreme Court really believes that the preemption clauses of FIFRA and the Medical Device Amendments are similar, then is the old Arkansas FIFRA precedent (Ciba-Geigy Corp. v. Alter, 309 Ark. 426, 834 S.W.2d 136 (1992)) still good law? In fact, now that we’re thinking about it, do defendants have room to maneuver in Montana, too? (Sleath v. West Montana Health Svcs., Inc., 304 Mont. 1,
16 P.3d 1042 (2000).)
We haven’t said much on this blog about how Riegel might apply to preemption analyses in other areas of law, but Despain suggests that some arguments that had appeared to be foreclosed to the defense may now have reopened.
Be on the lookout for those opportunities.