It’s a good day in suburban Philadelphia. The sun is shining, the snow is melting, Covid-19 cases are down nationwide, and we just got a text from the Drug and Device Law Rock Climber heralding a weekend visit (with the Irascible Rescue Pomeranian in tow). We are enjoying a welcome (if cautious) flash of optimism. And today’s case did nothing to dampen our spirits.
In Lim v. Ethicon, Inc., 2021 WL 612399, __ F. Supp. 3d __, (S.D. Miss. Feb. 12, 2021), the plaintiff alleged that she was injured by the defendant’s pelvic mesh device. She asserted claims under the Mississippi Product Liability Act for manufacturing defect, failure to warn, and design defect, and the defendant moved for summary judgment on all of the claims. Now, we move for summary judgment in medical device cases all the time, and we often report on others’ summary judgment motions in these pages. Over and over again, we see courts go off the rails because they misapply burdens of proof. Here’s what we mean: if the plaintiff bears the burden of proof on a substantive claim, and the defendant moves for summary judgment on that claim, the plaintiff is supposed to escape summary judgment only if she can adduce affirmative evidence satisfying her burden of proof on the elements of the claim. The plaintiff has to prove that she has evidence – the defendant doesn’t have to prove that there is no evidence. (We talk about this all the time in the warnings causation context – more about that in a minute.) But, too often, courts upend this, denying summary judgment because the defendant did not “prove the negative.” The Lim court got it right, three times.
As the court explained, “a manufacturing defect claim under the MPLA requires a showing that a product ‘deviated in a material way from the manufacturer’s or designer’s specifications or from otherwise identical units manufactured to the same manufacturing specifications.’” Lim, 2021 WL 612399 at *3 (citation to MPLA excluded). The plaintiff had no such evidence (they never do, in pelvic mesh cases). Because, as the court emphasized, “the plaintiff bears the burden of proving her manufacturing defect claim at trial,” (burden-of-proof “bingo” #1), the absence of evidence was fatal to the claim.
In Mississippi, a plaintiff cannot prevail on a design defect claim without proving that “an alternative design existed that would not impair the product’s usefulness or desirability [and that] would have to a reasonable probability prevented the harm.” Id. at *4 (citation omitted). The plaintiff alleged that her mesh device suffered from defects that included “roping, curling, fraying, particle loss, degradation, contraction and shrinkage, chronic foreign body reaction and decreased pore size.” Id. (We mention, parenthetically, that this litany appears in the report of every one of the ubiquitous mesh “experts” we face on a daily basis.) The court emphasized that, even “accepting this as true for purposes of” the summary judgment motion, the plaintiff could defeat summary judgment only if she could “present an alternative design that would have prevented the harm” the product allegedly caused. Id.
In the first place, the plaintiff purported to quote the report of one of her experts for the proposition that a safer alternative mesh design existed at the time of the plaintiff’s mesh implant surgery, but, as the court pointed out, the expert didn’t say any of this, in fact, he “[did] not discuss alternative designs . . . anywhere in his report.” Id. Never a good idea to make things up, but the court took it a step further, pointing out that, even if the expert actually had said these things, one of plaintiff’s other experts said the opposite, opining that the supposed “alternative” mesh has propensities that produce an “overall result [that] can be worse . . . .” Id. Finally, an “alternative” proposed by yet another of plaintiff’s experts did “not involve any implantation of a medical device;” rather, it was a completely different procedure involving tissue harvested from the plaintiff’s own body. Id. at *5. Under Mississippi law, like most everywhere else, this does not satisfy the requirement that a plaintiff identify a safer, feasible alternative design for an allegedly-defective product. (Here and here, you can see a couple of examples of posts on this.) Because the plaintiff had not “put forth evidence” that a “safer alternative design” for her mesh device existed at the time of her implant surgery, the court held that she could not “support her design defect claim,” and it granted summary judgment for the defendant. (Burden-of-proof “bingo” #2.)
Failure to Warn
Finally, we turn to “warnings causation,” one of our favorite doctrines but also one responsible for countless jurisprudential misadventures. Causation is an element of a failure-to-warn claim. Even if a plaintiff can prove that a warning was inadequate, she still must prove that the inadequate warning proximately caused her alleged injuries. Under Mississippi law, to escape summary judgment on warnings causation, the plaintiff must adduce evidence that an adequate warning would have “altered [the doctor’s] conduct” and would have “caused him not to implant” the product. Id. at *6. Again, this is an element of the claim, and the plaintiff has the burden of proving it.
In Lim, the plaintiff “did not claim that any additional warning” by the defendant “would have caused [the doctor] not to implant” the product. Instead, she “focus[ed] on her mistaken contention” that the defendant owed a duty to warn her directly – “that the learned intermediary doctrine does not apply in cases with medical devices.” To the contrary, the court emphasized, “it does.” Id. So the defendant’s duty to warn ran only to the doctor. In this case, the doctor testified that he was aware of all of the relevant risks from “his own medical training and research,” that the defendant’s warnings were “not something he would typically consult before implanting the device,” and that he “had not become familiar with the documentation before implanting” the device in the plaintiff. Id. Because the doctor did not rely on the defendant’s warnings, the plaintiff could adduce no evidence that any additional warning would have altered the doctor’s prescribing decision (you can see our roundup of similar failure-to-read cases here). And while the plaintiff also complained that the doctor did not warn her before her surgery, this was not enough for the plaintiff to “overcome her burden on summary judgment.” (Burden-of-proof “bingo” #3.)
Decisions like Lim bring us great joy because they fall squarely in our personal “wheelhouse” and give us hope for similar results. We’ll keep you posted on the good and the bad. In the meantime, stay safe out there.