Federal preemption of tort claims involving medical devices receiving premarket approval (PMA) is a powerful defense. But for some reason, there are plaintiff lawyers who think it does not apply, or barely applies, to claims for manufacturing defect. That is bad enough. When courts buy into that misconception, it is even worse. It takes clear thinking (and clear writing and clear oral argument) to explain how PMA preemption of manufacturing defect claims works. Sometimes it also takes persistence.
Today’s court opinion, Jacob v. Mentor Worldwide LLC, 2025 WL 2114888 (M.D. Fla. July 28, 2025), is short, but represents the culmination (maybe) of a long (six years) saga with many ups and downs — most of which should be familiar to readers of this blog. The plaintiff is a pro se former neurologist who claimed she lost her husband, her job, and her health after she got breast implants in 2007.
The plaintiff filed the lawsuit in 2019. The district court dismissed the complaint on preemption and other grounds (Rule 8 and 10). Jacob v. Mentor, 389 F.Supp.3d 1024 (M.D. Fla. 2019). The Blog covered this decision here: M.D. Fla. Holds Breast Implant Claims Preempted | Drug & Device Law
The plaintiff amended her complaint, and the district court again dismissed. Jacob v. Mentor, 2019 WL 6766574 (M.D. Fla. Dec. 10, 2019). The Blog covered this decision here: Breast Implant Preemption (the Sequel) | Drug & Device Law
So far, so good.
The plaintiff appealed. And then Covid-19 entered the picture. Delay ensued. The appeal languished in the Eleventh Circuit for years as the plaintiff sought and received more than ten extensions of time. Eventually, the court assigned the plaintiff an appointed appellate counsel. That appointed counsel must have done something right, or the Eleventh Circuit must have done something wrong, as the result was a reversal of the dismissal on appeal. Jacob v. Mentor, 40 F.4th 1329 (11th Cir. 2022). The Blog covered this decision here: Who Needs a Lawyer in the Eleventh Circuit? | Drug & Device Law
By “covered,” we mean derided. Indeed, the DDL Blog ranked this as one of the ten worst prescription drug/medical device decisions of 2022, coming in at #7: The Agony of Defeat -The Ten Worst Prescription Drug/Medical Device Decisions of 2022 | Drug & Device Law
The Eleventh Circuit remanded the case to the district court. The parties entered the maw of the great American discovery machine. When it became evident that the plaintiff’s pro se limitations were going to make discovery nearly impossible, the parties (i.e., at the defendant’s urging) agreed to bifurcate the issues, dealing with manufacturing defect first, and medical causation (which was extremely complicated given the plaintiff’s extensive medical problems and dozens of treating physicians) second. Smart move. Front-ending issues that have a good chance of terminating a case serves judicial economy. In fact, though plaintiff lawyers will deny it, such front-ending serves everyone’s economy.
After a brief period of discovery involving production of the defendant’s PMA manufacturing specifications and the plaintiff’s implants’ manufacturing records and a deposition of the plaintiff’s manufacturing defect expert (an inveterate breast implant critic), the defendant moved for summary judgment. The defendant argued that the plaintiff had no evidence that her implants deviated from their PMA specifications. The plaintiff’s expert did not compare the plaintiff’s implants against the PMA specifications. In fact, the plaintiff expert did not even review the PMA specifications.
By contrast, the defendant submitted a declaration from an engineer who reviewed the PMA specifications and the manufacturing records for the plaintiff’s implants and concluded they were manufactured in compliance with PMA specifications.
The defendant also moved to exclude each of the plaintiff’s three “experts” on amended Rule 702 grounds and for exclusion of the main expert’s opinions due to his spoliation. He had thrown out the implants while the case was on appeal without notice to the plaintiff or the defendant (which is why the defendant had to rely on manufacturing records instead of the actual implants).
We say this not because we are highly biased defense hacks (though we are), but because we are sentient beings: these defense motions were stone cold winners. Are we right about that? Well, yes and no.
Hunter S. Thompson said that when the going gets tough, the tough get weird. Things in the Jacob case got weird (or maybe the right word is “weirder”). At this point, we should mention that this is now two weeks in a row where we find ourselves blogging about strange legal doings in Florida. Last week we mentioned the now overused trope of Florida Man. We certainly do not mean to be sexist. Florida Woman can also bring the crazy.
The district court denied all of the defendant’s motions. Jacob v. Mentor, 2024 WL 1118811 (M.D. Fla. Mar. 14, 2024). The court even denied the motion on spoliation, holding that it was the defendant’s fault that the plaintiff’s expert disposed of the implants,even though the defendant had never possessed the implants and the plaintiff’s expert threw the implants out during the appeal process before discovery ever commenced in the district court.
When that sort of setback happens to us, we reconsider our career choice. Remember when that Heroes for Zeroes class taught by Professor Nagy made us think about getting a Ph.D in philology? Remember when the prospect of being a ranger at a national park seemed so alluring? Why-oh-why did we go to law school and set in motion 40 years of indignities?
But the defense lawyers in the Jacob case were made of stronger stuff than we are. There is psychological research suggesting that lawyers are less resilient than the general population. But the defense lawyers in the Jacob case countered that canard. They showed what resilience is. When a court gives you lemons, make lemon/reconsideration-ade. In this uncommon case, the defendant did something truly uncommon – it filed a motion for reconsideration and a request for oral argument.
In opposition, the plaintiff unleashed a blizzard of exasperation. It was as if the three letters P, M, and A operated as some sort of trigger. The plaintiff told the court (twice) that she had never accused the defendant of not following PMA specifications.
Hmmm.
Cue the flipping calendar pages. Time passed. For a long while, the defendant heard nothing on the motion for reconsideration.
The parties proceeded down the delightful path of discovery on medical causation and damages (for the next eight months), conducting depositions of many of the plaintiff’s physicians, none of whom thought her breast implants were responsible for her medical issues. Rather, they all believed her multiple issues stemmed from her pre-existing uncontrolled diabetes and lupus.
With certain deadlines approaching, and the parties needing additional time to conduct discovery, the parties jointly sought an extension of the case management order deadlines in January 2025.
Then, like a Floridian bolt from the blue, the court denied the motion for an extension of time and stayed the case pending a ruling on the long-pending motion for reconsideration. After some delays, the court granted the defendant’s motion for reconsideration as to the issue of preemption of the plaintiff’s manufacturing defect claim only. Jacob v. Mentor, 2025 WL 2114887 (Mar. 11, 2025). After more delays, the court held a hearing and then zeroed in on the key issue on which the defendant had originally moved for summary judgment (nearly two years prior) — that the plaintiff had no evidence that her breast implants deviated from their PMA specifications, which is a required element of a manufacturing defect claim against a Class III, PMA device in Florida. ’”Parallel’ state duties survive so long as they claim a violation of state tort law that aligns with a federal requirement. In contrast, a claim that a device violated state tort law notwithstanding compliance with the relevant federal requirements would clearly be preempted.”Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1326 (11th Cir. 2017) (citation and quotation marks omitted). See also Marmol v. St. Jude Med. Ctr., 132 F.Supp.3d 1359, 1365 (M.D. Fla. 2015) (required element is proof “[t]he defect resulted from a violation of a particular PMA requirement.”).
The Jacob court observed that the plaintiff’s sole expert on manufacturing defect had not even reviewed the defendant’s PMA specifications and had no opinions on whether they complied with or deviated from those specifications. The court also observed that because the plaintiff’s expert had disposed of the implants, neither he nor any expert could ever perform the required analysis of whether the implants were in compliance with their PMA specifications. The court reversed itself and granted the defendant summary judgment from the bench and dismissed the plaintiff’s case. The written opinion, short as it is, includes this: “Specifically, Plaintiff had failed to offer any competent expert testimony establishing that the alleged manufacturing defect resulted from a violation of a particular PMA requirement. Without such evidence, Plaintiff cannot proceed with a state-law based manufacturing defect claim that overcomes preemption.”
There is truth to the saying that justice delayed is justice denied, but a delayed win can still be a nice piece of vindication.
Big time kudos to the defense team: Dustin Rawlin and Monee Hanna of Nelson Mullins, and local counsel David Walz of Carlton Fields. Persistence paid off in this case. We’d like to think the case is over. But you know what Yogi Berra said.