For many years, the “one-two punch” was our affectionate label for post-Mensing cases that prevent innovator liability and preempt generic liability. But it’s been several years since we’ve used the expression this way because it was so effective in knocking out those cases, we just aren’t seeing them like we used to. So, it might be time to cast off the shackles of antiquated usage and allow the metaphor to once again roam freely in our lexicon to be used whenever two legal arguments reduce a case to rubble. Like in Klinker v. Johnson & Johnson, 2023 WL 358923 (E.D. Cal. Jan. 23, 2023), where the prescriber threw a jab knocking out failure to warn and plaintiff’s own expert delivered the cross that took out design defect.
Plaintiff underwent multiple surgeries to treat her urinary stress incontinence. Her first mesh implants were not manufactured by defendants. But her complaints of pain and other symptoms started then. Plaintiff’s treating surgeon decided to treat plaintiff by explanting the earlier mesh and implanting mesh manufactured by defendants. Id. at *1. Plaintiff brought claims for failure to warn and design defect and she failed to carry her burden of proof on either.
Under California’s learned intermediary doctrine, the plaintiff must prove not only the lack of an adequate warning but “also that the inadequacy or absence of the warning caused the [plaintiff’s] injury.” Id. at *4. In other words, if a different warning would not have changed the treatment decision of the prescriber, plaintiff cannot survive summary judgment. Here, the prescriber’s testimony was unequivocal. He did not remember reading the IFU that accompanied the product. He relied on his own training and research to inform him of the risks. He read the literature and studies on risk rather than rely on information from the manufacturer. Id. at *5. But that’s not all. Plaintiff’s surgeon also testified that he still believes today that use of defendant’s mesh was “the best option” for plaintiff. He “stood by” his treatment decision and still uses the mesh today. And, that defendants’ product was the “gold standard treatment” for urinary stress incontinence. Id. Plaintiff tried to rely on some less specific testimony that the surgeon does rely on manufactures to provide adequate warnings and that he likes as much information as possible. While that may be enough to create an inference that the surgeon generally relied on manufacturer warnings, it was not enough to create a triable issue regarding what he did in this particular instance—which was rely on his own research and training and stand by his treatment decision. Id. at *6. Without learned intermediary causation, plaintiff’s failure to warn claim was dismissed.
Unlike plaintiff’s treating surgeon, her expert was anything but specific. Nowhere in his report or testimony did he identify any specific defects in the product. He opined only that plaintiff’s injuries were caused by the “implanted mesh” or the “mesh placement.” Id. at *7. When asked what he meant, plaintiff’s expert said that implanted mesh is a “very broad non-specific statement, and it was written that way because it is not clear what caused what in this patient.” Id. And he is “not attributing a specific design defect in the mesh to [plaintiff’s] complications.” Id. But shouldn’t that have been precisely what he was hired to do? Given plaintiff had multiple types of mesh implanted, plaintiff’s experts conclusory opinion didn’t just fail to identify a defect, it failed to identify which mesh was a cause of her injuries. Since plaintiff could not explain how this “vague testimony establishes a causal link between a specific design defect in [defendant’s product] and [plaintiff’s] injuries, summary judgment on design defect was also granted.
In boxing the jab is used to lift your opponent’s head and expose his/her chin—a known weak spot. It didn’t take much to expose the weaknesses in Klinker and deliver a knockout.