The word of the day is targeted.  Targeted discovery on a targeting device and a district court laser-focused on the failure to warn causation target.  The end result is a decisive defense win on failure to warn.  See In re Biozorb Device Prods. Liab. Litig., 1:23-cv-10599-ADB, No. 1:22-CV-11895-ADB, 2025 WL 509834 (D. Mass. Feb. 14, 2025).

The BioZorb is a Class II medical device indicated for situations where an excision site needs to be marked for future medical procedures, like radiation treatment.  The device consists of a spiral-shaped spacer that dissolves into the body, leaving behind titanium clips that allow radiographic targeting.

The court’s case management order, agreed to by the parties, is a unique one.  See In re Biozorb Device Prods. Liab. Litig., 1:23-cv-10599-ADB, Dkt. 11 (D. Mass. Apr. 25, 2023).  The first phase is focused on the learned intermediary rule, allowing a core set of document discovery, depositions of the plaintiffs and the implanting physicians, and summary judgment motions on the learned intermediary rule.  Waves of cases were selected to proceed through this process.  This case was one of the first four bellwether trial plaintiffs, with Colorado supplying the applicable substantive law. We have reported on other cases in the group here and here.

In the case at bar, the implanting physician testified that she stands by her decision to use the BioZorb for the plaintiff (she also did not believe that the Plaintiff’s alleged injuries of pain and fibrosis were related to the BioZorb).  This type of testimony should, of course, result in summary judgment on failure to warn.

To try to avoid summary judgment, Plaintiff deployed a couple of tactics that sometimes lead courts astray. This court stayed on target. 

First, Plaintiff failed to ask the correct causation questions. Whether they did it deliberately we can’t say, but certainly plaintiffs’ counsel sometimes do.  The correct failure to warn causation inquiry is “whether a stronger warning would have changed [the implanter’s] decision to use the BioZorb.” 2025 WL 509834 at *4.  But Plaintiff’s counsel asked no such thing.  Instead, Plaintiff’s counsel “elicited testimony that Dr. Pomerenke was unaware of a variety of potential risks associated with the BioZorb.”  Id.  “Aha! Failure to warn causation!” says Plaintiff.  Not so fast.  Testimony that the doctor did not know certain alleged risks “cannot carry her burden at summary judgment, as it says nothing about the critical question on the issue of causation: that is, what Dr. Pomerenke would have done if she had known of those risks.”  Id. (emphasis the court’s). 

Second, lacking evidence of causation, Plaintiff trotted out the heeding presumption.  But Colorado does not recognize any such presumption. Rather, plaintiffs “must produce evidence that [the implanting physician] would not have used the BioZorb had the manufacturer provided adequate warnings.”  Id. at *3.

Under the staged discovery order, the other claims will be decided later, so this is only partial summary judgment on failure to warn.  But so far, this decision hits the mark.