We write a lot about the learned intermediary rule. It’s a fundamental aspect of the defense of drug and device cases, it’s grounded in the realities of the physician-patient relationship, and it tends to produce a lot of cases worth blogging about. We also refer to it as a rule (e.g., here, here, here, and here), rather than a doctrine, because that’s what it is. We particularly like it when courts dismiss warnings claims based on the learned intermediary rule at the pleadings stage. Today’s case is one of those. Plaintiff filed a shoddy complaint, was able to amend in response to an initial motion to dismiss, and then saw his warnings claims dismissed with prejudice under Alabama’s learned intermediary rule.
In McCrackin v. Rex Medical L.P., 2026 WL 66797 (N.D. Ala. Jan. 8, 2026), the plaintiff alleged he received an Option retrievable IVC filter in 2012. Twelve years later, he allegedly suffered complications when a “leg” from the filter fractured and penetrated a vein, with the further allegation that his spine grew around the fractured leg. He sued based on allegations that the device was marketed as permanent when it should have been temporary, and that there were not adequate warnings about the risk of “tilt, fracture, migration and/or perforation.” Id. at *1. Plaintiff previously obtained leave to file an amended complaint in response to an initial motion to dismiss, so this was his second bite at the apple. The defendant who marketed and distributed the device moved to dismiss.
Alabama
Alabama Supreme Court Applies AMLA Standards to Various Causes of Action
In the law, both form and substance matter. At the same time, we frequently see judicial opinions making the point that form should not be elevated over substance. Mottern v. Baptist Health System, Inc., 2024 WL 4097539 (Alabama Sept. 6, 2024), supplies a recent example. In Mottern, the Alabama Supreme Court permitted a plaintiff to…
We Applaud The Preemption Analysis And Outcome In Mack v. CooperSurgical, Inc. (2024) While Bemoaning Those In Mack v. CooperSurgical, Inc. (2023)
Note: There is a table in this post that may be easier to view on a phone than on a computer.
Medical device preemption provides powerful protection from litigation involving Class III devices with premarket approval (or “PMA”).
These devices are a very small subset of FDA-regulated medical devices – around 1% — and they…
M.D. Alabama Holds that Comment k Can Apply to Medical Devices
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…
Another Weird Alabama Decision
Alabama has always had some rather unusual jurisprudence. In product liability, the Yellowhammer State doesn’t have negligence or strict liability, but rather a hybrid called the Alabama Extended Manufacturers Liability Doctrine (“AEMLD”). See Casrell v. Altec Industries, Inc., 335 So.2d 128, 132-33 (Ala. 1976). More recently, the Alabama Supreme Court twice adopted the extreme pro-plaintiff innovator liability theory in Wyeth, Inc. v. Weeks, 2013 WL 135753 (Ala. Jan. 11, 2013), withdrawn and superseded, Wyeth, Inc. v. Weeks, 159 So.3d 649 (Ala. 2014). On that occasion, the Alabama legislature overruled the court. See Ala. C. §6-5-530. More recently than that, the same court authorized plaintiffs to perjure themselves and claim that they would have ignored their doctors’ recommendations in order to claim causation in learned intermediary cases. Blackburn v. Shire U.S., Inc., ___ So.3d ___, 2022 WL 4588887, at *11-12 (Ala. Sept. 30, 2022). Most recently, and most notoriously, the Alabama Supreme Court declared frozen embryos to be people – at least for the purposes of tort law. LePage v. Center for Reproductive Medicine, P.C., ___ So.3d ___, 2024 WL 656591, at *4 (Ala. Feb. 16, 2024). Who knows? By 2030, Alabama might attempt to count blastocysts as “people” for purposes of the census – although not for tort purposes, since the legislature appears to have stepped in again.
We read another bizarre – if not nearly as notorious – Alabama law decision recently. Ahmed v. Johnson & Johnson Healthcare Systems, Inc., 2024 WL 693078 (S.D. Ala. Feb. 20, 2024), reconsideration & certification denied, 2024 WL 947447 (S.D. Ala. March 5, 2024). What’s bizarre about it? It allowed a plaintiff in a medical device product liability case (hip implant) get to the jury without any medical expert testimony on causation. Id. at *16 (entitled “Summary Judgment is not Required on All of Plaintiff’s Claims Even Though She Offers No Expert Evidence Regarding Medical Causation”).
Continue Reading Another Weird Alabama DecisionGetting it Right on PMA Preemption
We all know that getting it right isn’t as easy as it sounds. Straightforward application of established law ought to be simple. If only it were so. Today’s decision gets it right, and we’re happy to report on Wilhite v. Medtronic, Inc., 2024 WL 968867 (N.D. Ala., Mar. 6, 2024).
Wilhite involved allegations that…
S.D. Alabama Tosses SJS Case Against Defendant that did not Make or Sell the Product
In 1972, Neil Young wrote his great song, “Alabama,” the lyrics of which included the following: “Alabama, you’ve got the rest of the union, to help you along; what’s going wrong?” Those lyrics occurred to us in 2013, when we read the Weeks decision, in which the Alabama Supreme Court endorsed innovator liability. We get…
An Unwelcome Twist On The Learned Intermediate Rule In Alabama
Regular readers of the blog know and appreciate our focus (fixation?) on the learned intermediary rule. Not because it is fun to say and makes us feel smart. No, we follow and write on the learned intermediary rule because it is a cornerstone of the law on allegedly inadequate drug and device warnings. It holds…
ND Alabama Finds Plaintiff’s Shotgun Pleadings a Mortal Sin (and Preempted) (and no Personal Jurisdiction)
While two-fer Tuesday has that nice alliterative ring to it – three-fer Tuesday gives you more bang for your buck. Pleadings, preemption, and personal jurisdiction. Maybe trifecta-Tuesday?
Plaintiff in Froman v. Coopersurgical, Inc., 2022 US Dist LEXIS 120725, *2-3 (N.D.AL Jul. 8, 2022) filed her complaint alleging that she suffered an injury when a…
Eleventh Circuit Certifies Two Learned Intermediary Questions to Alabama Supreme Court
Today’s case is not new to us. A year and a half ago we were extolling the virtues of Blackburn v. Shire U.S., Inc., 2020 WL 2840089 (N.D. Al. June 1, 2020), for granting summary judgment where the testimony from plaintiff and his prescribing physician shot holes in proximate causation too large for a…