This post is from the non-Reed Smith side of the blog.
The tone of today’s missive may be slightly more formal than most. For you see, as a result of binge watching Bridgerton on Netflix, the written word is being narrated in our head by the incomparable Julie Andrews. We so greatly esteem and admire Ms. Andrews that it is difficult to countenance her in the role of the villain. But, indeed a villain is what Lady Whistledown is. Sharing the most appalling of secrets; causing the ostracizing of some of the finest families of the Regency era. There is nothing Lady Whistledown is fonder of then a scandal. And, a scandal is precisely what garners our attention today in the opinion in Sharp v. St. Jude Medical, S.C., Inc., 2020 WL 7647511 (11th Cir. Dec. 23, 2020). So, like dear Whistledown, we take up quill and paper to warn our loyal readers of the injustice of this decision.
This is not our first dispatch dealing with Sharp v. St. Jude. As a brief reminder, the case involves a defibrillator that was implanted in Mr. Sharp and which Mrs. Sharp alleges malfunctioned, failing to deliver the necessary shock when Mr. Sharp went into cardiac arrest. Id. at *1. Seventeen months ago, when the trial court reviewed Mrs. Sharp’s complaint, it rendered a commendable decision dismissing all of Mrs. Sharp’s claims for both failing to state a claim and on the grounds of PMA preemption. We told you all about that triumph here. Not content with that ruling, Mrs. Sharp filed an appeal asking the appellate court to reconsider only her manufacturing defect claims, thereby abandoning her failure to warn and negligence per se claims. Id. Certainly, such an application would not have been entertained at the court of Queen Charlotte. But modern times call for modern measures.
The only issue formally addressed by the Eleventh Circuit was whether Mrs. Sharp adequately stated a claim for a manufacturing defect under Georgia law, concluding that the trial court’s preemption decision was ancillary only. Id. at *6n.2. Unfortunately, in a two-to-one decision, the appellate court concluded that Mrs. Sharp’s complaint had sufficient substance to withstand a dismissal at the pleadings stage. First, the court embraced Mrs. Sharp’s allegations that the defendant failed to manufacture the device in accordance with its PMA requirements, such as the requirement for consistent insulation diameters. Id. at *2-3.
The court was also persuaded that allegations of violations of the FDA’s CGMPs were an appropriate basis for a manufacturing claim. Id. at 3. If you are truly a loyal reader, you will already be aware of our belief that CGMPs are much too vague to be the basis for a parallel manufacturing defect claim. While potentially enough to satisfy TwIqbal, hardly adequate to elude preemption. In this scenario, Mrs. Sharp referenced an FDA inspection of the manufacturer’s facility conducted in 2009 that identified “numerous potential violations.” Id. (emphasis added). As any mother of “the ton” knows, there is a vast distinction between having numerous potential suitors and having one declared proposal.
Mrs. Sharp’s last allegation was that a 2011 recall was circumstantial evidence of a defect. Id. The Eleventh Circuit opinion discusses the recall only in the context of a defect and stops short of examining whether it also constitutes evidence of an FDCA manufacturing violation. The court was willing to amalgamate these allegations and circumstantial evidence to conclude that Mrs. Sharp had alleged enough to allow her claim to proceed. Id. at *4-5.
This blog takes solace in knowing that it was not the only illuminator compelled to pen displeasure with the court’s decision. A dissenting voice took issue as well. Pointing out, for example, that evidence of a recall could possibly support a design defect, but not a manufacturing defect claim. Id. at *6. As for Mrs. Sharp’s PMA-related allegations, the dissent found they suffered from a “timing issue.” Decidedly so, as the PMA regulations alleged to have been violated post-dated the manufacture of Mr. Sharp’s device. The defendant should not be held accountable for violating regulations that did not exist at the time of manufacture. Id. Finally, our like-minded dissenter found the GCMPs too general to support Mrs. Sharp’s claim. “It’s not self-evident to me what those failures have to do with manufacturing-defect claims, and Sharp doesn’t do much to help us connect the dots.” Id. Without a connection, there cannot be causation. Yet another fatal flaw in Mrs. Sharp’s case.
Suffice it to say we do not consider this decision to be this season’s diamond. Far from it. It reads much more like an empty dance card; hollow and disappointing. Fear not good readers, there are diamonds and triumphs yet to come. Just like Lady Whistledown, we will hunt them down and reveal their secrets.