Now that federal court pelvic mesh cases no longer disappear into that black hole that was the multidistrict litigation, the difference seems almost like daytime after a long, dark night. Rather than piling up on the docket for years – unreviewed and inert (except for adding to the settlement pressure of large numbers), these complaints are actually subject to judicial review. A case in point is the recent decision in Hix v. Boston Scientific Corp., 2019 WL 6003456 (D. Ariz. Nov. 14, 2019). The court in Hix TwIqballed most of the plaintiff’s claims. How often does one bring a successful TwIqbal motion in an MDL?

Plaintiff in Hix pleaded “eleven causes of action.” Id. at *1. At the end of the opinion, four were left: an unchallenged design defect claim, warning-related claims solely involving plaintiff’s “physicians” in negligence and strict liability, and an express warranty claim. Id. at *3 n.3, *9. In between the following happened:

  • Plaintiff could not assert “consumer expectations” in a manufacturing defect claim. “[T]he consumer expectation test has little utility in manufacturing defect cases, such as this one, where the plaintiffs are not alleging that the defective product was ever safely produced.” at *4.
  • Plaintiff also had the “burden [of] identifying the specific manufacturing defect.”
  • “[S]ummary allegations that the [device] . . . failed to perform as designed and intended, without explanation as to how those defects are tied to the manufacturing process, do not demonstrate that the [it] had a manufacturing defect.” at *4.
  • “Plaintiffs’ failure to warn claims can only be based on the information provided, or not provided, to [plaintiffs’] physicians, not Plaintiffs themselves or the general public.” at *5. Warning claims focused on “Plaintiffs and the general public” are dismissed. Id.
  • “[G]eneralized allegations of misrepresentation, concealment, and unspecified sales and marketing materials lack sufficient particularity under Rule 9(b).” at *7.
  • Misrepresentation-based claims are also dismissed because they “fail[] to identify the particular individuals who made the misrepresentations and concealments. Rather, the Amended Complaint only generally refers to [the defendant].”
  • “Plaintiffs have not demonstrated that they are entitled to punitive damages and their request for such relief will be dismissed” because they do not allege “that there has been a final determination of wrongdoing by the FDA” as required by Ariz. Rev. Stat. §12-689(B)(2). Hix, 2019 WL 6003456, at *8.

Beyond that, plaintiffs were put on notice that, although their express warranty claim survived Rule 12 dismissal, they will have to establish both what the “specific” warranties are, and how they became the “basis of the bargain” − how the plaintiff implanted with the device actually relied on the warranty. Id. at *6.

It sure is nice to see the Federal Rules of Civil Procedure actually being enforced. It’s been a long time coming.