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This post is from the non-Reed Smith side of the blog.

We could have titled today’s post something like Back to Basics or Legal Writing 101 because that is how the opinion in McGuire v. Abbott Laboratories, Inc., 2022 WL 4295402 (E.D. Tex. Sep. 15, 2022) reads.  In other words, it provides a lot of detail on the legal framework and then reaches a conclusion with very little fanfare.  The opinion is simple and straightforward and so we will attempt to be too.

The product at issue was an implantable cardioverter defibrillator (“ICD”), which is a Class III, Pre-Market approval medical device.  Defendant moved to dismiss all claims as preempted and for failure to satisfy the TwIqbal pleading standards.  Id. at *1. 

The decision starts with a notably lengthy discussion of the pleading standards.  The court devotes several paragraphs to conclusory allegations.  Explaining, for example, that in deciding a motion to dismiss, while the court must accept plaintiff’s factual allegations as true—the court should not “strain” to “accept conclusory allegations, unwarranted deductions, or legal conclusions.”  Id. In fact, conclusory allegations should not be accepted as true by the court.  Id. at *2 (citation omitted).  The court cannot guess at the factual support.  It is up to plaintiff to provide sufficient details to make the requested relief “plausible, not merely conceivable, when taken as true.”  Id. 

Next, the court explains why it can take judicial notice of two PMA approval letters from the FDA.  Because the letters are publicly available and relevant to an issue to be decided—whether the product is governed by FDA regulations.   And, because defendants asked.  Id. at *3.

The court next discussed federal preemption both generally and as it pertains to PMA medical devices.  Specifically, the two-prong test of Riegel.  The ICD automatically satisfies prong one—it is subject to federal regulations—because it underwent the FDA’s PMA process.  Id. at *4.  Prong two is whether plaintiff’s claims are in conflict with those federal regulations or run parallel to them.  If the former, they are preempted.  Id. at *5.  Which brings us to the court’s conclusion – the intersection between TwIqbal and Riegel:

[Plaintiff] asserts product liability and negligence causes of action against [the manufacturer] related to the manufacture, design, and marketing of the [PMA medical device]. [Plaintiff]’s petition, however, does not plead a violation of any federal requirement relating to the manufacture, design, or marketing of the [device]. Moreover, there are no facts set forth in the petition supporting a finding of any such violation. [Plaintiff] fails to point out any specific defect in the manufacturing process or design, any deviation from the FDA-approved design or manufacturing process, or any causal connection between a violation of federal requirements and his injuries. . . . Thus, [plaintiff]’s claims are too conclusory to be deemed parallel claims that are not subject to preemption under § 360k(a).

Id. at *5

Summed up nice and neat—plaintiff’s complaint simply was not enough to “nudge the claims across the line from conceivable to plausible.”  Id. at *2 (citation omitted).

And, plaintiff could not fix their conclusory pleadings by relying on res ipsa loquitur.  Simply because the device malfunctioned “does not establish [defendant’s] negligence.”  Id. at *5.  A device can fail without violating an FDA safety standard.  Id.  Plaintiff is getting a second bite at the apple, but they are going to need more than res ipsa loquitur to avoid the same outcome a second time.