Trial Preparation Continues with First BioZorb Bellwethers Just Months Away

Some BioZorb lawsuit cases will soon go to trial, marking a key moment in the litigation.

The first of the lawsuits, which claim the breast cancer marker devices caused serious complications in some patients, is set to go to trial on Sep. 8, 2025. A second trial is officially set for Jan. 20, 2026 as well.

With the initial trial just six months away, preparations are well underway. The judge overseeing the cases in federal court in the Massachusetts district recently outlined pretrial schedules for both cases. This schedule outlines key deadlines for the first trial throughout the summer, such as requests for the court to rule on admissible evidence.

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The bellwether trials could play a crucial role in the direction of the litigation. While the results do not directly impact other trials, they do help establish a sense of where the litigation is heading.

Early wins for plaintiffs may mean defendants will face more losses in future trials. Knowing this, the defendants might feel pressured into a settlement. Conversely, if the defendants see success in the bellwethers, that could damage the pending cases for other plaintiffs.

Lawsuits Claim BioZorb Caused Serious, Painful Complications in Patients

Lawsuits began to emerge involving BioZorb, which is manufactured by Hologic, following a recall of the devices in March last year.

BioZorb is a breast cancer marker implanted in soft tissue to assist in identifying tissues for future medical treatment.

But Hologic opted to recall the devices after receiving reports of numerous serious complications. These complications include device migration and erosion, pain, discomfort, rash and infection. According to the Food and Drug Administration, the move was classified as a Class I recall, the most serious kind.

“Use of these devices may cause serious injuries or death,” the agency stated.

Hologic went on to recall lots of unused BioZorb devices in October as well.

Patients who claim to have been impacted by these concerns have filed many lawsuits. According to the U.S. Securities and Exchange Commission, about 100 people have filed BioZorb lawsuits.

The vast majority of the cases are pending in the U.S. District Court for the District of Massachusetts. Lawyers continue to investigate and accept new cases.

Editor Lindsay Donaldson contributed to this article.