Products Liability Law Daily Wrap Up, DESIGN AND MANUFACTURING DEFECTS—MEDICAL DEVICES—D. Mass.: BioZorb supplier denied dismissal of design defect claims in patients’ injury action, (Mar 18, 2025)

By Pankhuri Bhatnagar, B.A. LL.B.

The patients’ claims survived as they sufficiently alleged design defects based on the product’s operational failure of not absorbing in the body, migrating, causing infections, and requiring removal.

In an action brought against a medical device supplier by several women who were implanted with a BioZorb device during their breast cancer treatment, the federal district court in Massachusetts denied the supplier’s motion to dismiss. The court found that the patients plausibly alleged a product defect, described how the supplier failed to avoid foreseeable risks by not considering clinical data and other reports concerning the defects, identified safer variations of the product’s existing design, and satisfied the requirements of the applicable state laws (In re: BioZorb Device Products Liability Litigation, No. 22-cv-11895-ADB (D. Mass. Mar. 14, 2025)).

Background. Several women residing in different states received surgical treatment for breast cancer, during which they were implanted with BioZorb markers. The BioZorb is a class II medical device cleared by the Food and Drug Administration and consists of a bioabsorbable spacer that holds six radiopaque titanium clips. The spacer material is intended to be resorbed by the body within “one or more years,” leaving the clips as permanent indicators of the tissue site for future medical procedures. Believing that they were harmed by the device’s defective design, the patients brought suit against Hologic Inc. (supplier), which was responsible for the BioZorb’s design, research, development, testing, packaging, labeling, and supply. They claimed that Hologic knew or should have known that the device may fail to resorb, require an increase in a patient’s radiation dose, and cause infection, fluid buildup, device migration, skin erosion, pain, discomfort, and rashes, potentially necessitating device removal. The supplier moved to dismiss the patients’ design defect counts.

Product defect. The supplier submitted that the allegation that the BioZorb’s design was “defective because of design aspects, including but not limited to, its shape, surface, texture, material, and integration of parts” was a conclusory laundry list that failed to “identify any particular aspect of the BioZorb’s design that constituted a defect,” as required under all the relevant states’ laws. However, the complaint explained that the cited aspects were defective because their design could lead the device to not fully absorb in the body, migrate, be expelled from the body, or cause an infection. It was also clear that the defect derived from the product’s bioabsorbable scaffolding. These allegations were consistent with pleadings readily accepted in other courts that characterized a plausible defect based on the product’s operational failure, rather than a concrete engineering deficiency that led to the failure.

Causation. Hologic argued that the women did not allege that the device defects resulted from any negligent conduct on its part. The patients responded that their allegations concerning Hologic’s knowledge about the defects, coupled with the allegation that Hologic “failed to take reasonable measures to mitigate or eliminate the risks posed by the defective design,” were sufficient at this stage. They pointed out clinical evidence, incident reports, and a 2024 FDA Safety Communication that reported adverse events consistent with the alleged defects. Moreover, the supplier sought to obtain FDA approval for the BioZorb as “designed to improve cosmetic outcomes”; the FDA concluded that it lacked clinical data to support that the device in fact improved such outcomes; and Hologic nevertheless continued to understand the device as being designed in a manner appropriate for that purpose. Taken together, these allegations showed that the supplier breached its duty to exercise reasonable care to avoid foreseeable risks by failing to account for clinical data and other information about its product’s advantages, risks, and efficacy. Thus, Hologic had sufficient notice of the women’s causation theory.

Alternate designs. The patients asserted that there were technologically feasible and practical alternative designs that would have reduced or prevented their harm and that such designs were mechanically feasible, safer, and cost less than the BioZorb. Hologic pointed out that they did not identify any particular alternative design, as required by the respective state laws. The women answered that an alternative design would involve embodiments where the scaffolding would not lead to migration or a failure to resorb, and also referred to non-scaffolded titanium clips as a design. Hologic argued that titanium clips were a “different product,” not an alternative design of the BioZorb. Tersigni v. Wyeth, 817 F.3d 364, 368 (1st Cir. 2016).

The court disagreed, noting that titanium clips were a key component of the BioZorb and provided the radiographical utility for its FDA-approved purpose. The complaint cited clinical studies explaining that titanium clips used without the BioZorb’s scaffolding aspect were likewise used to mark the tumor bed in breast cancer treatment and were more cost-effective. These facts were distinct from Tersigni, where the claimants only alleged that “there were other, safer methods of weight loss available.” Here, the women did not merely point to other surgical or radiology techniques that would obviate the need for use of a BioZorb. They proposed that Hologic’s product could have been “more safely designed” by manufacturing titanium clips without the allegedly defective scaffolding material, and not, as in Tersigni, that a “different product was somehow safer.” This was sufficient to survive the supplier’s objections.

Risk-benefit test. Finally, Hologic contended that the women failed to state a claim under Colorado, Michigan, and Washington laws, which require a risk-benefit or consumer expectation analysis to “demonstrat[e] that, on balance, the risk of danger inherent in a challenged design outweigh[ed] the benefits of such a design.” Barton v. Adams Rental, Inc., 938 P.2d 532, 537 (Colo. Sup. Ct. 1997). The court explained that the risk-utility analysis in Colorado applies only to claims alleging strict products liability, not design defect claims based on negligence. Bartholic v. Scripto-Tokai Corp., 140 F. Supp. 2d 1098, 1106, 1111 (D. Colo. 2000). Washington also follows the same rule. Payne v. Paugh, 360 P.3d 39, 54 (Wash. App. 2015). As for Michigan, Hologic cited McClarty v. C.R. Bard Inc., No. 14-cv-13627, 2020 WL 6075520, at *4 (E.D. Mich. Oct. 15, 2020) to argue that a risk-utility analysis is required on a negligence claim. The McClarty factors boiled down to a “demonstrat[ion] [of] the magnitude of risks involved,” that such risks were “foreseeable,” and a “reasonable alternative design.” Here, the women alleged that the BioZorb’s design posed a “high gravity of danger,” that Hologic knew or should have known about these risks, and that alternative designs existed. Thus, the supplier’s motion was denied.

The case is No. 22-cv-11895-ADB.

Judge: Burroughs, A.

Attorneys: John J. Roddy (Bailey & Glasser LLP) for Shelley Evers, Christina Patras and Rita Melkonian. Andrew Hannemann (Arnold & Porter Kaye Scholer LLP) for Hologic, Inc.

Companies: Hologic, Inc.

MainStory: TopStory DesignManufacturingNews MedicalDevicesNews CausationNews MassachusettsNews