Here are a couple of recent developments that we don’t want to let get stale.

Oglesby v. Medtronic, Inc., 2024 WL 1283341 (5th Cir. March 26, 2024), is an excellent, but unfortunately unpublished, affirmance of summary judgment under Texas law in medical device case.  Plaintiff brought various claims, and appealed the dismissal of two of them, the allegations of manufacturing defect and inadequate warnings.

As to manufacturing defect, the plaintiffs did what plaintiffs usually do with such claims – fail to allege what the actual defect was.  In Texas (as elsewhere) “[a] manufacturing defect exists when a product deviates, in its construction or quality, from the specifications or planned output.”  2024 WL 1283341, at *1 (citation and quotation marks omitted).  Rather than have any theory of what that deviation might have been, plaintiffs claimed that the medical device had “malfunctioned” and that the claimed malfunction in and of itself was sufficient “circumstantial evidence” of a defect.  Id. at *1-2.

No way – at least not in Texas.

Oglesby correctly rejected the 30+ year old intermediate appellate decisions plaintiffs cited in favor of more recent decisions by the Texas Supreme Court:  Gharda USA, Inc. v. Control Solutions, Inc., 464 S.W.3d 338, 352 (Tex. 2015) (“[t]o be successful on a manufacturing defect claim, the plaintiff must identify a specific defect by competent evidence”); Ford Motor Co. v. Ledesma, 242 S.W.3d 32, 42 (Tex. 2007) (“the deviation from design that caused the injury must be identified”); Nissan Motor Co. v. Armstrong, 145 S.W.3d 131, 137 (Tex. 2004) (“a specific defect must be identified by competent evidence”).  Thus, “plaintiffs must allege a specific deviation from the product’s intended design that allegedly caused the injury”). Norman v. Bodum USA, Inc., 44 F.4th 270, 272 (5th Cir. 2022).  In Oglesby, the plaintiffs didn’t even try to meet their manufacturing defect burden.  “[N]one of [their] evidence establishes a specific manufacturing defect.”  2024 WL 1283341, at *2.

While a specific defect may be proven by circumstantial evidence, that does not eliminate the requirement to allege the existence of a specific defect in the first place. Oglesby failed to do so.

Id.

Nor did plaintiffs rule out other possible reasons for the claimed product failure, since their own expert opined that it was equally likely that something other than a product defect could have occurred.  “When the circumstances are equally consistent with either of two facts, neither fact may be inferred.”  Id. (citation and quotation marks omitted).

Ditto for negligent manufacturing.  “[A] manufacturer logically cannot be held liable for failing to exercise ordinary care when producing a product that is not defective.”  Id. at *3 (citation and quotation marks omitted).

As for failure to warn, that claim failed in Oglesby, under the learned intermediary rule, due to our old friend physician failure to read.  A warning, no matter how deficient the plaintiff might claim it to be, cannot possibly be causal when it was never read.  Thus, Oglesby held:

[Plaintiffs] did not establish a genuine dispute of material fact on causation.  [The] physician testified that he could not recall reading a product manual or any other [of defendant’s] resources about the . . . product, that he “probably” did not read the . . . product’s instructions for use when preparing for [the] surgery or when he first learned about [the product], and that he “maybe” had not ever read the instructions for use.

2024 WL 1283341, at *3.  Plaintiff had no contrary evidence, so summary judgment on warning causation was likewise affirmed.

The second opinion, Bernstein v. Actavis Pharma, Inc., 2024 WL 1908963 (Mo. Cir. April 25, 2024), is likewise unpublished – because all Missouri trial court opinions are unpublished.  But unlike all other Missouri trial court opinions of which we are aware, the court in Bernstein granted an opposed motion based on FDCA preemption.  The only other pro-preemption Missouri trial court opinion that we know of, McDonald v. Lester E. Cox Medical Centers, 2014 WL 58773  (Mo. Cir. Jan. 2, 2014), was unopposed.

Bernstein involved three generic drug manufacturers sued by the plaintiffs for wrongful death.  2024 WL 1908963, at *1.  Generic preemption, as courts from the United States Supreme Court on down have recognized, is broad, given the statutory “sameness” requirement imposed on manufacturers of generic drugs.  Id. at *2.  Plaintiffs in Bernstein made the usual allegations about the defendants’ drugs being “misbranded” – to no avail.

The rule of sameness applies to claims that a drug has been misbranded as well.  Misbranded drugs are those whose labels do not bear adequate warnings. . . .  While courts and the FDA have acknowledged that generic drug manufacturers who become aware of safety problems must ask the FDA to work toward strengthening the label warning, generic manufacturers still may not change a label unilaterally.  Additionally, generic manufacturers are not required to stop selling an allegedly misbranded or unsafe drug in order to comply with both state and federal law nor to avoid liability.

Id. (citations and footnote omitted).

Because plaintiffs’ strict liability claims were “based on the premise that the generic drugs produced by defendants were misbranded, were defective in design, and were unreasonably dangerous, id. at *3, they were necessarily preempted. 

To permit plaintiffs’ products liability claims to proceed under Missouri law, based on failure to warn or defective design, would require these generic drug manufacturers to unilaterally change their label without going through the process proscribed by the FDA and federal law.

Id.  State law cannot force defendants to violate supreme federal law.  Id. (“the laws are in conflict; it would be impossible for the defendant drug manufacturers to comply with both”).  Id.

Consumer protection and fraud claims in Bernstein were also dismissed, because these fraud-based claims were inadequately pleaded.  Consumer protection claims do not lie in Missouri for personal injury claims, since the statute “specifically excludes” them, and plaintiffs had not pleaded anything else.  Id. at *3-4 (“plaintiffs’ allegations are the sorts of conclusory allegations that are insufficient under the required pleading standard”) (citation omitted).  Straight-up fraud claims were likewise inadequate, for failure to allege reliance, among other things.  Id. at *4.

The claims that Bernstein dismissed on non-preemption grounds likewise involve product information, thus eventually they should also fail as preempted.  But there’s a limit to what one can expect a St. Louis (County, not City) court to do all at once.  Bernstein remains a ground-breaking defense win in a difficult jurisdiction.  We congratulate the Blank Rome team that won Bernstein and were thoughtful enough to let us know about it.