We hope we have some 1980s cartoon fans out there who will remember that G.I. Joe ended each of his cartoons with a PSA – “Now you know. And knowing is half the battle . . .” The PSA was usually about something dangerous kids did unintentionally—like running out into traffic. The idea was that once kids knew about a risk, they would take the necessary steps to avoid it. Turns out the same thing applies to learned intermediaries. It is not enough that they are aware of the risks of a medical device, but knowledge of those risks must spur them to take a different course of action. Otherwise, as the plaintiff in In re Biozorb Device Products Liability Litigation, learned—there is no failure to warn causation. 2025 U.S. Dist. LEXIS 18654 (D. Mass. Feb. 3, 2025).
Plaintiffs in this litigation have brought failure to warn, design defect, breach of implied warranty, and negligence claims against the manufacturer of an implantable medical device used as a marker for procedures such as radiation treatment. The product is designed to dissolve or reabsorb over time, leaving just clips that allow for radiographic targeting. The device’s Instructions for Use state that the reabsorption could take one or more years. Id. at *9-10. Plaintiffs allege that the extend reabsorption time led to complications, including pain, a palpable mass, and the need for explant surgery.
Plaintiff who is the subject of this decision was one of four bellwether plaintiffs whose case was proceeding through phased discovery. Phase one was discovery related to failure to warn and the learned intermediary doctrine. Following the deposition of plaintiff’s implanting physician, defendant moved for summary judgment. That testimony included that the surgeon had been using the device for 3-5 years at the time of plaintiff’s surgery and he was aware the reabsorption process could be prolonged. Id. at *11-12. He was also asked about an FDA Safety Communication that came out in 2024, six years after plaintiff’s surgery. He testified that most of the risks identified in 2024 were risks common to any kind of surgery with any kind of implantable device, such as infection and seroma. Id. at *13-14. Finally, the surgeon was asked whether he still would have implanted the device in plaintiff in 2018 had he known about the risks described in the FDA Safety Communication. He testified that he would and that he still does. Id. at *14-15.
Against that factual background, the court was compelled to award summary judgment to defendant on plaintiff’s failure to warn claim. Plaintiff was a resident of Michigan, where she also had her surgery and sustained her alleged injuries. So, the court applied Michigan learned intermediary law. Under which
[t]o establish the element of proximate causation, a plaintiff must show that an adequate warning would have prevented the plaintiff’s injury by altering the prescribing doctor’s conduct or that the doctor might have heeded the warning.
Id. at *18.
Because the implanting surgeon testified that additional warnings would not have changed his conduct, plaintiff tried to argue that a material dispute existed regarding the surgeon’s actual knowledge of the risks at the time he prescribed the device. But the doctor’s awareness, or even lack thereof, “says nothing about the critical question on the issue of causation: that is, what [the doctor] would have done had he known of those risks.” Id. at *20 (emphasis in original). Plaintiff cited no Michigan law for the proposition that a lack of knowledge alone is sufficient to defeat summary judgment. It does not.
After G.I Joe gave his lesson, the cartoon kids crowded around and yelled Now we know! Learned intermediaries may shout the same. But knowing or not knowing isn’t enough. Action based on knowledge is what is required–both by kids learning not to play in traffic and surgeons acting as learned intermediaries.