Lewis v. Johnson & Johnson’s Empirical Analysis

Citation profile

2 state decisions

Most-quoted passages

The sentences later courts lift from this opinion, ranked by how many decisions quote each — the parts of the opinion doing the work. These counts are smaller than the citation total above because most of the 11 citing decisions cite the case generally; a passage count includes only decisions quoting that exact language verbatim.

1. “[T]he court stated that bringing in such evidence would result in a "mini-trial" about (1) the strengths and weaknesses of the process and (2) whether [the defendant] had in fact made all of the disclosures it should have made during the process. [The defendant's] evidence would have initiated a battle of experts: [the defendant] was prepared to characterize the review process as "thorough" and "robust" and the FDA's clearance of the Avaulta Plus as "an affirmative safety ... decision" based on "specific safety and efficacy findings." [The plaintiff] was prepared to argue, as she has done before this Court, that these characterizations wildly inflate the significance of the process, and that in any event [the defendant] failed to make necessary disclosures to the FDA. All of this, the district court reasoned, presented "the very substantial dangers of misleading the jury and confusing the issues." The court expressed concern that subjecting the jury to many hours, and possibly days, of complex testimony about regulatory compliance could lead jurors to erroneously conclude that regulatory compliance proved product safety. In other words, having a "mini-trial" could easily inflate the perceived importance of compliance and distract the jury from the central question before it-whether [the defendant's] design was unreasonable based on any dangers it posed versus the costs required to avoid them. While 510(k) clearance might, at least tangentially, say something about the safety ”

   3 later decisions quote this exact passage · from the majority
   e.g. Eghnayem v. Boston Scientific Corp. · Carlino, S. v. Ethicon, Inc.

2. “Ethicon’s argument ignores the fact that the Prolene suture and the TVT are two -entirely different medical devices that went through different FDA processes. Although Ethicon represents that-the products are primarily composed of'the same material, it does not automatically follow that the material is safe in both devices. The Prolene suture is a nonab-sorbable surgical suture; the TVT is a form of transvaginal mesh. The Prolene suture consists of a single, filament of polypropylene; the TVT is a mesh woven from knitted Prolene filaments. The average Prolene suture is a few inches long; the TVT measures one-half inches by sixteen inches, and contains many times the amount of polypropylene material. The Prolene suture is not intended to adhere to human tissue; the TVT is designed to adhere to human tissue. The Prolene suture is designed to be easily pulled out of the body; the TVT cannot be removed without invasive surgery.”

   3 later decisions quote this exact passage · from the majority
   e.g. Mullins v. Johnson & Johnson · 30 F. Supp. 3d 554 - Edwards v. Ethicon, Inc.

3. ““[pjersuasive authority from other district courts ... indicates that the preemption analysis is not applied differently to the component parts of a medical device and the medical device itselff.]” Gavin v. Medtronic, Inc., CIV.A. 12-0851, 2013 WL 3791612 , at (E.D.La. July 19, 2013). Interestingly, the shoe is normally on the other foot — the defendant is arguing that a cause of action is preempted because a device underwent premarket approval, while the plaintiff is arguing there is no preemption because a component part of the device underwent 510(k) clearance. Courts addressing this issue have determined that a device should not be broken into its component parts in order to apply a preemption analysis.... The same reasoning used in those cases is applicable here: analyzing the component parts of a device separately from the device itself simply does not make sense. “To require that a distinction be drawn between the approval process of the individual components of a system and the system itself, would, it seems, add a level of complication to the medical device approval process not anticipated by Congress, the FDA, or medical device manufacturers.” Lewkut, 724 F.Supp.2d at 656. “It makes no sense — indeed, it would probably be impossible — to pick apart the components of a medical device and apply different preemption analyses to different components.” Riley, 625 F.Supp.2d at 780. Determining preemption based upon the component parts of a device, rather than the device a”

   2 later decisions quote this exact passage · from the majority
   e.g. 30 F. Supp. 3d 554 - Edwards v. Ethicon, Inc. · 29 F. Supp. 3d 736 - Huskey v. Ethicon, Inc.