On Monday, it’s the aura and majesty of the Supreme Court of the United States, descanting grandiloquently about issues of national importance.
On Tuesday, it’s the Appellate Court of Connecticut droning on about comment (k) to the Restatement.
On this blog, you never know what you’ll get.
Bad news: It’s Tuesday.
In Breen v. Synthes-Stratec, Inc., 108 Conn. App. 105, 947 A.2d 383, 2008 Conn. App. LEXIS 261 (Conn. Ct. App. May 27, 2008), Breen broke his leg. The orthopedic surgeon treated it in part by implanting a bone plate. Six months later, the plate broke. Breen sued Synthes, which manufactured the plate.
Synthes won at trial; Breen appealed.
The court would have none of it.
Although comment (k) expressly mentions only “drugs,” “vaccines,” and “experimental drugs” as unavoidably unsafe products, those examples are illustrative only: The Restatement says that the same (unavoidable unsafeness) “‘is true of many other drugs, vaccines, and the like.'” (Slip op. at 5, quoting Restatement (Second) of Torts, Sec. 402A, comment (k).) Medical devices are included among “the like.”
Moreover, the Connecticut Supreme Court has “applied the learned intermediary doctrine, which is supported by comment (k), in the context of prescription implantable medical devices.” Slip op. at 5, citing Hurley v. Heart Physicians, P.C., 278 Conn. 305, 317, 898 A.2d 777 (2006).
Actually, not quite enough said.
Breen also asserted that the learned intermediary doctrine and comment (k) apply only to medical devices that the FDA classifies as “class III” — “represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury.” According to Breen, the learned intermediary doctrine should not apply to class II devices, such as Synthes’ bone plates.
The Connecticut court would have none of it, because Breen had presented no argument supporting that distinction.
Along the way, the Connecticut court collected cases from many different states applying comment (k) (slip op. at n.5) and the learned intermediary doctrine (slip op. at n.6) to medical devices.
That’s today’s news.
Maybe tomorrow we’ll be surprised by something out of the U. S. Supreme Court.