Smith v. Angiodynamics, Inc., 2024 U.S. Dist. LEXIS 73561 (M.D. Alabama April 23, 2024), offers the veritable mixed bag of rulings. The plaintiff alleged that an implanted vascular device fractured, resulting in pieces of the device migrating to the plaintiff’s heart. The plaintiff underwent surgery to remove the fragments.  The plaintiff’s lawsuit included claims for (1) violation of the Alabama Extended Manufacturer’s Liability Doctrine (AEMLD); (2) negligence; (3) breach of warranties; and (4) wantonness. The defendant filed a motion to dismiss all of the claims.  The plaintiff conceded that the warranty claims were goners, but otherwise resisted the motion.  The court ended up not dismissing any of the claims (except the conceded warranty causes of action), but said a few things that might comfort a flinty defense hack’s heart. 

The most significant and positive (from the defense hack heart perspective) portion of the Smith opinion provided an affirmative answer to whether Restatement (Second) of Torts section 402A, Comment k principles apply to medical devices in addition to drugs. Comment k calls off strict liability claims against “unavoidably unsafe” products.  In law school, we learned that explosives and circus lions were unavoidably unsafe. In practice, we learned that prescription drugs also fall into that category.  But what about medical devices?  

The Smith court held that comment k can apply to medical devices, which is the majority rule.  That’s good.  But the court also was “unwilling to apply a blanket rule of application across all medical devices.”  Thus, the court held that Comment k applies only on a case-by-case basis, which is not so good, but is also the majority rule.  Because the Smith court could not “discern at this early stage of the proceedings whether Comment k should apply,” it denied the motion to dismiss the design defect claim.  Of course, we would have called it a day after determining that the medical device in question was available only via prescription. Under the DDL blog worldview, Comment k would apply, so goodbye to strict liability design defect.  But since (checking our mail) no one has nominated us to an Article III judgeship, our highly biased opinion matters hardly at all. 

Also notable in the Smith decision is the holding that Comment k applies to negligence and wantonness (an Alabama peculiarity) claims, which is a less common ruling.  The wantonness claim is not subsumed by the AEMLD, but because it is still propelled in this case by an assertion that “the product at issue is defective,” Comment k should apply here. Nevertheless, because the Smith court by its own account “punts the issue of Comment k under the AEMLD to a later stage … the issue will also be punted as to Smith’s defective design claims brought under the theories of negligence and wanton mess.”   That’s a lot of punting in Alabama. We doubt that Nick Saban would approve. 

The Smith court held that the learned intermediary rule applies to medical devices, which seems an obvious enough point.  But the Smith court concluded that the plaintiff pleaded enough non-physician-specific smoke that the court denied dismissal on that ground. There was reference to underreporting of adverse events and provision of “incomplete, insufficient, and misleading information to physicians.”  We agree with the defendant that such allegations were too general, vague, and conclusory to carry the day for the plaintiff, but the Smith court saw that issue differently. 

We’re not huge fans of The Grateful Dead, but for some reason the lyrics to “Alabama Getaway” are ringing through the DDL noggin right now.