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 Jan. 11, 2013), withdrawn and superseded, Wyeth, Inc. v. Weeks, 159 So.3d 649 (Ala. 2014).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”).
That’s just plain weird. We may agree or disagree with other aspects of Ahmed (see below), but nothing else leave us scratching our heads. As we pointed out recently, the Sixth Circuit became the first federal court of appeals to examine all fifty states and hold that each and every one of them requires expert medical testimony to establish causation:
[A]s an MDL, the issue was governed by the substantive state law of the transferor state. So the court reviewed the law of all fifty states, concluding that all states require the plaintiff in cases involving complex issues of medical causation to present expert testimony on the subject. The district court does not stand alone: other district courts have agreed that all jurisdictions require expert testimony to show general causation, at least where the issues are medically complex and outside common knowledge and lay experience.
In re Onglyza (Saxagliptin) & Kombiglyze (Saxagliptin & Metformin) Products Liability Litigation, ___ F.4th ___, 2024 WL 577372, at *6 (6th Cir. Feb. 13, 2024) (citing In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 227 F. Supp.3d 452, 469-78 (D.S.C. 2017) (collecting cases), aff’d, 892 F.3d 624 (9th Cir. 2018), and In re Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II), 387 F. Supp.3d 323, 341 (S.D.N.Y. 2019), aff’d, 982 F.3d 113 (2d Cir. 2020)) (other citations, quotation marks, and footnotes omitted).
Indeed, shortly after the above-quoted Mirena decision, we compiled a 50-state survey of this issue in 2019, entitled “Prescription Medical Product Causation – Expert Required.” That post collected all caselaw, as of 2019 (it is not updated) to demonstrate that every state in the union requires expert causation in complex product liability cases. At that point, in addition to the two decisions cited in Onglyza, we counted five other MDL decisions for the same proposition.
In addition, we had the following to say about Alabama law:
Under Alabama law, expert testimony is required to establish causation where “the nature and origin” of the injury is “beyond the understanding of the average person.” Ex parte Trinity Industries, Inc., 680 So.2d 262, 269 (Ala. 1996). Thus, “[p]laintiffs must prove the toxicity of [a product] and that it had a toxic effect on them causing the injuries that they suffered,” and “[t]his type of proof requires expert testimony.” McClain v. Metabolife International, Inc., 401 F.3d 1233, 1237 (11th Cir. 2005) (applying Alabama law).
The interaction between a complex and technical medical device and the unique physiological and medical circumstances of the patient in which it is implanted is a subject on which no ordinary juror could rationally be expected to have knowledge. The net result is that, without the benefit of expert testimony, a reasonable jury could not possibly make a determination . . . that [plaintiff’s] injuries were caused by a . . . defect in the [product].
Hughes v. Stryker Sales Corp., 2010 WL 1961051, at *5 (S.D. Ala. May 13, 2010), aff’d, 423 F. Appx. 878, 881 (5th Cir. 2011) (on basis of district court’s reasoning). “[I]n the typical case involving a complex medical device, the absence of expert testimony would force a jury to engage in speculation and conjecture on issues of defect and causation,” thus “courts routinely require expert testimony in such matters.” Id.
Thus, “Alabama courts consistently have opined that . . ., when the product at issue is of a complex and technical nature, the plaintiff’s proof of a defect should be in the form of expert testimony. Bloodsworth v. Smith & Nephew, Inc., 476 F. Supp.2d 1348, 1353 n.3 (M.D. Ala. 2006). See Drake v. Ortho-McNeil-Janssen Pharmaceuticals, 2018 WL 1431646 (N.D. Ala. March 22, 2018) (“[d]ue to the complex nature of the claims, expert testimony generally is required to establish general and specific causation in product liability cases”); Brantley v. International Paper Co., 2017 WL 2292767, at *16 (M.D. Ala. May 24, 2017) (“The plaintiffs must establish both general and specific causation through expert evidence.”); Jones v. Novartis Pharmaceuticals Corp., 2017 WL 553134, at *17 (N.D. Ala. Feb. 10, 2017) (“plaintiffs must provide expert testimony to establish both general and specific causation”), aff’d, 720 F. Appx. 1006 (11th Cir. 2018); Benkwith v. Matrixx Initiatives, Inc., 467 F. Supp.2d 1316, 1332 (M.D. Ala. 2006) (plaintiff “must present expert evidence on general causation. Without proof of causation, she cannot prevail”) (citation omitted); Sutherland v. Matrixx Initiatives, Inc., 2006 WL 6617000, at *14 (N.D. Ala. 2006) (“without an expert to connect a toxin to an injury, there is no toxic tort”); Emody v. Medtronic, Inc., 238 F. Supp.2d 1291, 1295 (N.D. Ala. 2003) (“An essential element of all product liability cases is expert testimony . . . that a defect was the medical cause of plaintiff’s claimed injuries.”).
So how could Ahmed go so far astray?
Ahmed is not a case where the plaintiff had no experts at all. Rather, as the above heading we quoted states, plaintiff did not have any medical testimony. Plaintiff did have an engineer paid to offer a “failure analysis” opinion about the device itself. 2024 WL 693078, at *6. Even though this engineer has “never analyzed” any sort of plastic implant before Ahmed, he was found qualified due to his general “background and decades of experience.” Id. However, as even Ahmed admitted, “engineers are not qualified to offer opinions as to medical causation.” Id. at *11.
Who is? A medical doctor.
But plaintiff still did not have any admissible medical testimony. And we think she needed it. Here is a thumbnail timeline of the medical history. Hip implantation surgery; six weeks later a “popping sound” when “getting up”; another month and “she told her doctor that the hip pops and locks up sometimes”; nearly a month later, she fell; the next day, x-rays showed the implant “eccentrically located,” leading to revision surgery. Id. at *2, 16. Did the “eccentricity” pre-date the fall, or did the fall cause it? No doctor ever opined on that.
Plaintiff did have a doctor lined up – but for some reason (never explained) only as a “rebuttal witness.” Ahmed, 2024 WL 693078, at *13. A rebuttal witness is just that – not permitted to testify in the plaintiff’s case in chief, but “solely to contradict or rebut evidence on the same subject matter identified by another party.” Id. (citation and quotation marks omitted).
[Defendant’s medical] opinion is that plaintiff’s “medical procedures to repair and replace her right hip were primarily unsuccessful for patient-specific reasons and not as the result of any defect in the . . . components used.” . . . [Plaintiff’s rebuttal witness] will then rebut [the defense] opinion that patient-specific factors were responsible by testifying that [plaintiff’s] failed total hip replacement was “multifactorial.”
Id. at *13 (citations omitted). Okay, but still no witness can so opine in plaintiff’s case in chief – and plaintiff bears the burden of proof.
The rebuttal witness “may not testify in plaintiff’s case-in-chief to establish medical causation.” Id. at *14. Along those lines, since that rebuttal witness was limited to critiquing the defense witness, he “did not conduct a differential diagnosis in this case and was not required to do so.” Id. at *15. That means that this medical witness could not offer the critical medical causation opinion that Alabama law (and the law of every other state in the country) required. So the plaintiff in Ahmed unquestionably did not have any medical causation testimony for her case in chief.
Ahmed let plaintiff skate on this fundamental causation point by holding that the case wasn’t actually “complex” after all. Citing nothing – only distinguishing the defendant’s authority – Ahmed held: “even if whether the [implant’s] failure caused Plaintiff’s injuries was in dispute, it would be within a juror’s purview that the damages over which Plaintiff sues resulted from the [implant’s] failure and not some alternate cause.” 2024 WL 693078, at *17. Why? Pure “temporal relationship.” Id. But the Eleventh Circuit (like other courts) has said “no” to that.
The issue of the chronological relationship leads to another important point − proving a temporal relationship between [product use] and the onset of symptoms does not establish a causal relationship. In other words, simply because a person [uses a product] and then suffers an injury does not show causation. Drawing such a conclusion from temporal relationships leads to the blunder of the post hoc ergo propter hoc fallacy. The post hoc ergo propter hoc fallacy assumes causality from temporal sequence. . . . It is called a fallacy because it makes an assumption based on the false inference that a temporal relationship proves a causal relationship.
McClain v. Metabolife International, Inc., 401 F.3d 1233, 1243 (11th Cir. 2005) (citation omitted). That’s precisely why expert testimony is required – so “that decision makers will not be misled by the post hoc ergo propter hoc fallacy − the fallacy of assuming that because a biological injury occurred after [an event], it must have been caused by [that event].” Id. (citation and quotation marks omitted).
Nonetheless, Ahmed held, based solely on the engineering testimony about defect – that “in this case it is certainly a ‘natural inference’ that a juror could make through human experience that Plaintiff’s . . . damages concentrated in [her] right hip – proximately resulted from the Hip Implant having failed.” 2024 WL 693078, at *17. The “supporting” citation, to Allison v. McGhan Medical Corp., 184 F.3d 1300 (11th Cir. 1999) (applying Georgia law), is anything but supportive, since Allison specifically held that lack of medical expert testimony (after Rule 702 exclusion) was fatal and required summary judgment in that case. Allison, 184 F.3d at 1320 (“medical expert testimony was essential to prove causation in this case”).
This result in Ahmed – that a plaintiff can get to the jury without any medical expert at all in a case involving alleged injuries from an implanted medical device – appears both unprecedented and unsupported. Even granting plaintiffs everything their engineering expert could opine: that the device was “defective” and therefore could fail for the design reasons so stated, nothing excludes plaintiff’s fall the day before as the medical cause of the “eccentric” positioning that led to the revision surgery and what followed.
Aside from that huge error, however, not all of Ahmed was horrible. Specifically, another aspect of the plaintiff’s same engineering expert’s testimony, concerning purported alternative designs, was excluded because none of them actually existed and had actually been tested for feasibility. This was not a case where either the defendant, or a competitor, had brought any of the supposed alternatives to market. Ahmed, 2024 WL 693078, at *9 (expert “was unable to reliably point to any specific competitor design”). Given the lack of real world experience with the claimed alternatives, testing was a necessary part of the basis for that opinion:
[The expert] is excluded from testifying at trial regarding any alternative design proposals that may have been available to Defendants in manufacturing the allegedly defective [device]. It appears from the [record] that he merely conceptualized possibilities when suggesting changes to the [device design], which are an insufficiently reliable basis for proposing alternative designs.
Id. (citations and quotation marks omitted). “[A]pplicable case law suggests that the failure to test a proposed alternative design or cite another’s testing of the design is fatal to the admissibility of said testimony.” Id. Plaintiff’s failure to establish any alternative design required dismissal of both plaintiff’s AEMLD and negligent design claims, for which an alternative design is an essential element. Id. at *18.
That’s a nice enough secondary holding, but overall, the holding in Ahmed that a plaintiff can establish medical causation without any medical testimony was both wrong and unprecedented.