This article from the Minneapolis Star-Tribune reminded us of the simmering controversy about reprocessing medical devices that are labeled for single-use. Folks in the device and health care industries know the story: manufacturers produce certain medical devices labeled for single use only. Hospitals use the devices once; reprocessors sterilize the devices; and hospitals buy the sterilized devices and re-use them in new patients. Commentators raise issues about both whether the devices are safe when re-used and whether patients should be told as part of the informed consent process that they are being treated with reprocessed devices that were labeled for single use.
This is a tricky issue for us to discuss — not because we don’t have opinions, but because of who we are and what we do for a living. We typically represent drug and device manufacturers in product liability cases. But we both have colleagues who represent hospitals or other health care providers. And there’s always a chance that a reprocessor will call us one day, and who knows where zealous advocacy will lead then? So we won’t say publicly anything about the merits of the on-going debate.
We’ll say only this: As litigators, we’re called into action after smoldering issues like this one have ignited into legal infernos. And, if that ever happens here, all of the players in the single-use device controversy will look back with regret on the things they’ve said so stridently before the litigation began. A manufacturer’s protestation that a device labeled for single-use is unsafe if reprocessed, a hospital’s statement about the need to control costs, a reprocessor’s claim that manufacturers are just protecting profits — all of these comments can come back to haunt all of the players collectively.
Take it from a couple of guys who have been there and done that: Turn the volume down a notch, folks. It’s surely possible to discuss these issues without making accusations that may ultimately redound to everyone’s collective detriment. Be careful what you say in public; some day, you may be held to your words.