The pelvic mesh case of the week – McBroom v. Ethicon, Inc., 2022 WL 604889 (D. Arizona March 1, 2022) – focuses on the regulatory status of the device. We always knew it was an important issue, and McBroom provides yet another reason why that is so.
As you must know by now, the pelvic mesh MDL court ruled that the FDA 510(k) regulatory clearance of pelvic mesh devices was irrelevant because such clearance was not probative of safety. The MDL court was wrong about that because 510(k) clearance means the device was found to be substantially similar to another device with proven safety and efficacy. The MDL court’s reliance on the old SCOTUS Lohr case, which contrasted 510(k) clearance with more rigorous premarket approval, dealt with preemption, not admissibility. Lohr also antedated the Safe Medical Devices Act of 1990, which strengthened the 510(k) process. But the MDL error remains and has had the pernicious effect of deceiving juries into thinking that pelvic mesh devices received no regulatory review.
Whether or not a court follows the MDL error, 510(k) clearance must be considered when there is a state law that affords it substantive significance. In Arizona, a manufacturer cannot be liable for punitive damages if the product was “designed, manufactured, packaged, labeled, sold or represented in relevant and material respects according to the terms of an approval, conditional approval, clearance, license or similar determination of a government agency.” We have written about this excellent Arizona statute several times, including here and here.
The Arizona legislature passed the punitive damages exemption statute in August of 2012. The plaintiff in McBroom argued that the statute could not retroactively divest her of her right to punitive damages. The plaintiff claimed that her right to punitive damages vested no later than April 2012, when she experienced symptoms. But the plaintiff did not file her lawsuit until March of 2015. Any right to punitive damages could not have vested until she filed lawsuit. Hence, the statute applied.
Nevertheless, the plaintiff argued that one of the pelvic mesh devices implanted in her in 2007 was not covered by the statute because such device had not received FDA 510(k) clearance at that time. The product had initially been marketed as a line extension of another product. After some FDA inquiries, the defendant eventually submitted a separate 510(k) application for the product, and it was cleared in May of 2008. The McBroom court rejected the plaintiff’s clever argument for three reasons: (1) temporality is meaningless in this context because every product is necessarily designed before it receives regulatory clearance or approval; (2) the Arizona statute set timing requirements for some things, but not for application of the punitive damages exemption; and (3) Arizona law reserves punitive damages for only “the most egregious cases” involving “reprehensible conduct” (isn’t or shouldn’t that be the law everywhere?), and the fact is that the Arizona legislature said that a manufacturer did not commit egregious conduct if its product passed regulatory muster.
There is nothing wrong with the court’s analysis, but we would have dispatched the plaintiff’s punitive damages argument even more quickly. To our eyes, the whole vesting punitive damages argument is bunk. There is no ‘right’ to punitive damages at all. Because punitive are not compensatory, there is nothing to vest – before or after a lawsuit is filed. Maybe some right attaches after a verdict, but certainly not before. We wrote here about how there is no constitutional right to punitive damages, and there is an Arizona Supreme Court case among the many cases rejecting any impediment to state legislatures changing the rules on punitive damages.
Let’s get back to McBroom.
The plaintiff argued that the mesh manufacturer lost the right to invoke the statute when it took the device off the market rather than perform randomized trials of the product as required by a 2012 FDA 522 order. But the Arizona statute specified that it was called off if the product was sold after the government agency issued a final order to remove the product from the market, or withdrew approval, or substantially altered its terms of approval. That did not happen in the McBroom case.
The plaintiff also engaged in a bit of sophistry by contending that the mesh device was not a “product” within the meaning of the Arizona statute once it was withdrawn from the market. The court pointed out that the statute defined the term “product” and it was not required that the product currently be on the market.
The result was that the plaintiff in McBroom could not present any evidence nor argument on punitive damages. McBroom was a clean sweep on punitives.
The McBroom court went on to rule that, unless the defense somehow opened the door, the plaintiff could not present evidence that a device had been marketed prior to FDA clearance.
The plaintiff wanted to tell the jury that the defendant had removed the pelvic mesh device from the market. We get why the plaintiff wanted to parade this fact before the jury. But the defense should then be entitled to show that the product had been cleared by the FDA and never been uncleared. And then the plaintiff would want to discuss the curious timing about how a device had been implanted before it was cleared. As the McBroom court said, “[i]t’s a slippery slope.” It’s also a headache. The McBroom court concluded that it was “a difficult issue” and it would be better positioned to make a determination at trial. Normally, we would grouse about a court punting on such an important issue, but the court might have a point about how the context of trial would help inform where best to draw the line.
The issue of what to do about the fact that a product is no longer marketed is a tricky one. If punitive damages were in play – which, as you learned above, they are not in the McBroom case – it might be better for the defense if the jury knew the product was no longer sold. Further, we labor under the suspicion that there will always be at least one or two jurors who ignore the court’s admonitions against internet research and will find out anyway about product withdrawals. If that is so, might it not be better to face up to the issue and explain? But it is a dicey, case-by-case analysis.
The last issue discussed by the McBroom court was the admissibility of medical device reports (MDRs). The McBroom court joined prevailing authority in ruling that MDRs contain hearsay and cannot constitute evidence of a product defect. But because there might be circumstances in which MDRs put a manufacturer on notice, and because the plaintiff had not specified which MDRs she was proffering, the court delayed ruling until trial. Here, the court’s punting seems a little less justifiable. The plaintiff should have been forced to put up or shut up, and we vote for the latter.