Court Clears BioZorb Lawsuit Design Defect Claims Over Recalled Breast Tissue Marker

Manufacturer’s motion to dismiss design defect claims in BioZorb lawsuits was rejected, based on plaintiffs’ allegations that older tissue marker designs did not cause similar complications.

A federal judge has rejected a motion to dismiss filed by the manufacturer of the BioZorb tissue marker, allowing design defect claims to proceed, after finding that plaintiffs sufficiently pled allegations that the device’s form and materials can prevent it from adequately absorbing into the body, resulting in painful complications that often require surgical removal.

The BioZorb Marker is a small implant approved for use among breast cancer survivors and other individuals who require targeted radiation therapy. It consists of a biodegradable spacer made from polylactic acid, and six permanent titanium clips. 

Although the BioZorb Marker is designed to gradually break down and dissolve into the body, leaving only the clips behind to aid in the precise marking of previously removed tumor sites, breast cancer survivors have reported experiencing severe pain, discomfort and other BioZorb marker injuries when the device failed to absorb.

In October 2024, the U.S. Food and Drug Administration (FDA) announced a BioZorb recall, removing all BioZorb implants from the market after the manufacturer acknowledged that there were a higher-than-expected rate of problems, including incidents where the marker failed, resulting in the need for surgical removal of the device.

Since then, more than 100 BioZorb lawsuits have been brought against Hologic, Inc., each alleging that the breast tissue marker was defectively designed and unreasonably dangerous, exposing patients to a risk of pain, infection, rash, device migration, erosion and other complications.

Currently, all BioZorb lawsuits have been filed in the U.S. District Court for the District of Massachusetts, where Hologic is located. Given similar allegations and claims raised in the complaints, the litigation has been consolidated before U.S. District Judge Allison D. Burroughs, who is presiding over coordinated discovery and preparing a small group of cases for early trial dates.

In November 2024, Hologic filed a motion to dismiss BioZorb design defect claims raised in several lawsuits, which were filed by Shelley Evers, Christina Patras, Rita Melkonian and Tricia Willard, saying that the allegations were improperly pled, and fail to actually point out a defect in the BioZorb design based on certain state laws.

However, Judge Burroughs issued a Memorandum and Order (PDF) on March 14, rejecting the arguments and clearing the way for the claims to move forward. The decision is also expected to effectively prevent the BioZorb manufacturer from using that argument in other claims similarly filed.

“Plaintiffs both identify defective components and explain the nature of the underlying defects, and, contrary to Hologic’s view that Plaintiffs must identify a more specific defective aspect of the BioZorb, these allegations are adequate,” Judge Burroughs wrote. “On its face, the Amended Complaints allege that the defective aspects of the BioZorb are its ‘shape, surface, texture, material, and integration of parts,’ and, more to the point, that such aspects are defective because their design may lead the device ‘not [to] fully absorb in the body,’ to ‘migrate[],’ to be ‘expelled from the body,’ or to ‘cause[] an infection’. It is also readily apparent and easily inferred that Plaintiffs’ allegation is that the defect derives, at least in part, from the bioabsorbable scaffolding.”

Judge Burroughs said the plaintiff’s design defect claims are plausible, “and not merely speculative or possible” that the BioZorb implant is defectively designed. She also notes that plaintiffs properly noted that there are other breast tissue markers on the market that predate BioZorb, which plaintiffs say are safer designs.

BioZorb Bellwether Trials

Lawyers involved in the litigation are expected to meet with Judge Burroughs for a status conference on Monday, March 31, 2025, to discuss the progress preparing a small group of cases for early bellwether trial dates.

In July 2024, the Court ordered the parties to select a group of 10 BioZorb lawsuits for a “bellwether” process, with each side designating five cases for a Discovery Pool. 

Those BioZorb injury cases have been going through depositions, exchange of medical records and other case-specific discovery, to help the parties gather information to select a smaller group of cases to present to juries as early test cases.

In December 2024, the parties whittled that list down to four bellwether trial candidates, and in January 2025, Judge Burroughs announced that the first BioZorb lawsuit bellwether trial will begin on September 8, 2025.

While the outcome of these early trial dates will not have any impact on other claims being pursued against the manufacturer, the average BioZorb lawsuit payouts awarded by juries are likely to have a substantial impact on settlement negotiations needed to avoid each claim ultimately being set for trial in the future.