BioZorb Lawyers Propose Four Lawsuits Over Recalled Tissue Marker To Prepare for Trials Starting in Sept. 2025

To help gauge how juries may respond to certain evidence and testimony that will be repeated throughout a growing number of BioZorb lawsuits being pursued over the recalled tissue markers, lawyers have selected four cases that will be prepared for a series of early bellwether trials, which are expected to begin in early September 2025.

The BioZorb tissue marker is a small implant used to pinpoint areas for targeted radiation therapy in breast cancer patients, which consists of a biodegradable spacer made from polylactic acid and six permanent titanium clips.

While the implant is supposed to gradually break down and dissolve in the body, leaving only the clips in place to aid in the precise marketing of previous surgical tumor removal sites, a growing number of patients have reported experiencing painful BioZorb complications when the tissue marker failed to absorb into the body. In many cases, this has led to the need for surgical removal of the BioZorb marker.

The size and scope of the litigation has begun to rapidly increase over the past few months, after the manufacturer, Hologic, decided to initiate a BioZorb recall in October 2024, urging doctors to return any devices that have not been implanted and to closely monitor patients with the marker currently implanted in their breast tissue.

Nearly identical allegations have been raised in dozens of BioZorb lawsuits filed by breast cancer patients who report that the device has migrated, fractured, or caused other injuries. As a result of common questions raised by each of the plaintiffs, the complaints are currently consolidated before U.S. District Judge Allison D. Burroughs in the District of Massachusetts, where the manufacturer’s U.S. headquarters are located.

BioZorb Bellwether Trial Selections

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.

In July 2024, Judge Burroughs directed the parties to select a group of 10 BioZorb lawsuits for the 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 a proposed case management order (PDF) filed by BioZorb lawyers involved in the litigation on December 19, four cases have been identified that will be eligible to serve as the first bellwether trials.

All of the plaintiffs filed their lawsuits as part of multi-plaintiff complaints, with two of the plaintiffs selected coming from the same complaint (PDF) filed in January 2023.

The first plaintiff listed from that complaint is Cynthia Kresh, of South Carolina, who was diagnosed with ductal carcinoma and underwent a lumpectomy in October 2020, during which a BioZorb marker was implanted. However, after the surgery Kresh suffered lymphedema, a large abscess and a wound which did not close for more than a year, resulting in recurring staph infections. A broken piece of the BioZorb marker began poking through her flesh in 2022, which led to surgery to remove the remaining pieces of the broken implant.

The parties also named Kimberly Taylor as a trial pool plaintiff, who filed as part of the same lawsuit as Kresh. Taylor, from New York, underwent a breast cancer lumpectomy in June 2021, during which she received her BioZorb implant. However, she had to undergo a mastectomy to remove the implant after it was discovered not to be absorbing into her body.

Beth Deuel is another plaintiff selected for the trial pool, who submitted her claim as part of another multi-plaintiff complaint (PDF) filed in March 2023. Deuel, from Michigan, received her BioZorb during a lumpectomy in May 2018, but the device stuck out of her chest, causing severe pain and discomfort. She had the implant removed in May 2022.

The fourth plaintiff selected for the trial pool was Pamela Gibson, of Colorado, who received her BioZorb marker in June 2020. She reports to have suffered pain, a hard lump, deformity, scarring, fibrosis, seroma and other complications since the BioZorb was implanted. Gibson indicates she is unable to sleep comfortably because of the implant. She has not yet had the device surgically removed. She filed her complaint (PDF) with several other plaintiffs in March 2023.

In addition to selecting the four trial pool plaintiffs, the parties also proposed a system for selecting the order of trials randomly by January 17. They estimate each trial will take about three weeks, with the first trial beginning on September 8, 2025, and the second trial beginning in January 2026.

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.