Hologic Seeks To Dismiss BioZorb Design Defect Claims in Lawsuits Over Recalled Tissue Marker

Although a BioZorb recall has been issued for all versions of the breast tissue marker, Hologic is asking the court to throw out claims alleging injuries were caused by design defects.

The manufacturer of the BioZorb tissue marker is asking a federal judge to throw out claims alleging that injuries were caused by design defects associated with the implant, even though the company has issued a massive recall, urging all doctors to immediately stop using BioZorb markers and return all unused devices.

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

The implant is designed to gradually break down and dissolve in the body, leaving only the clips in place to aid in the precise marking of previous surgical tumor removal sites.  However, an alarming number of patients have experienced painful BioZorb complications when the tissue marker failed to absorb in the body, often resulting in the need for surgical removal.

Although a partial recall was issued earlier this year, after the U.S. Food and Drug Administration (FDA) indicated that hundreds of complaints had been received involving the tissue maker, Hologic expanded the BioZorb recall on October 25, urging doctors to return any devices that have not been implanted and closely monitor patients with the marker implanted in their breast tissue.

Hologic now faces dozens of BioZorb lawsuits brought by breast cancer survivors who indicate that the device migrated, fractured or caused other injuries, which are consolidated before one judge in the U.S. District Court for the District of Massachusetts, where the manufacturer’s U.S. headquarters are located.

On November 11, the manufacturer filed a motion to dismiss (PDF), asking U.S. District Judge Allison D. Burroughs to throw out all design defect claims in a group of early “bellwether” cases.

Despite recalling BioZorb devices only two weeks earlier, Hologic argues that plaintiffs’ complaints fail to name an actual defect or specific design problem with the tissue marker, which should exclude them from making design defect claims. The company also claims that many of the lawsuits fail to meet state-specific requirements for design defects, based on where the plaintiffs live.

However, the design defect claims only comprise a portion of each complaint. Even if Hologic convinces Judge Burroughs to dismiss those parts of the lawsuits, the litigation would move forward on failure to warn, negligent misrepresentation, manufacturing defect and other claims.

Biozorb Bellwether Trials

To help move the litigation forward and promote potential BioZorb recall settlement negotiations, Judge Burroughs has established a bellwether process, where a small group of representative claims are being prepared for early trial dates to help gauge how juries may respond to evidence and expert testimony that is likely to be repeated throughout the litigation.

In July 2024, Judge Burroughs directed the parties to select a group of BioZorb lawsuits for the bellwether process, with each side designating five cases for a Discovery Pool. Those BioZorb injury cases are going through depositions, exchange of medical records and other case-specific discovery, which is expected to be completed by December 16, 2024.

Judge Burroughs has indicated that the initial pool of bellwether cases will eventually be narrowed down to a group of four cases, which will be eligible for the first trial dates, which are expected to be ready to go before juries  by the summer of 2025.

While the outcome of any 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.