Four BioZorb Breast Tissue Marker Lawsuits Selected for Bellwether Trials

Lawyers indicate that they are on track for the first BioZorb lawsuit over the recalled tissue marker to go before a jury in September 2025.

As a growing number of BioZorb lawsuits continue to be filed over painful complications associated with the recalled breast tissue markers, lawyers involved in the litigation have identified the first four claims that will go before a jury, for a series of early test trials scheduled to begin later this year.

The lawsuits involve problems with BioZorb markers, which are small implants used during breast cancer treatments, consisting of a biodegradable spacer made from polylactic acid and six permanent titanium clips.

Although the BioZorb is supposed to gradually break down and dissolve in the body, leaving only the clips in place to mark the location for targeted radiation therapy, women have been complaining for years about continuing pain, discomfort and issues where the device migrated out of position or even protruded painfully through the skin, often resulting in the need for the breast tissue marker to be surgically removed.

Following a large number of adverse event reports and BioZorb breast tissue marker lawsuits filed by patients, the manufacturer issued a global recall in October 2024. 

In addition, the U.S. Food and Drug Administration issued a scathing warning letter to Hologic, Inc. in January 2025, outlining a number of problems discovered during an inspection of the manufacturer’s Massachusetts facility.

There are now at least 122 total plaintiffs involved in about 30 separate BioZorb marker lawsuits, according to recent court documents. However, the size of the litigation is expected to continue to increase in the coming months, as more women learn that their implant may have failed to dissolve properly due to design defects, leaving them with painful injuries and the need for removal surgery.

Given common questions of fact and law raised in each of the complaints brought in the U.S. District Court for the District of Massachusetts, where the manufacturer’s headquarters are located, the litigation has been centralized before Judge Allison D. Burroughs for coordinated pretrial proceedings and a series of early test trials, which are currently scheduled to begin in September 2025.

BioZorb Breast Tissue Marker Bellwether Selections

Before the recall was even issued, Judge Burroughs had already directed the parties to select a group of 10 BioZorb lawsuits for a “bellwether” process, with each side designating five cases that have gone through coordinated discovery and been prepared for early test trials.

In a joint status report (PDF) submitted by the plaintiffs and defendants on March 28, those cases were narrowed down to four final Trial Pool claims, with two of the cases selected by the plaintiffs, and two selected by the manufacturer.

The two plaintiffs’ picks involve claims brought by Kimberly Taylor and Cynthia Kresch on a multi-plaintiff lawsuit (PDF) originally filed in January 2023.

Taylor, of New York, received her BioZorb breast tissue marker implant in June 2021, after being diagnosed with breast cancer. However, the lawsuit indicates, “Ms. Taylor suffered pain, a hard lump, and inflammation at the site of the BioZorb. She had to massage it every day to help keep the inflammation down.” 

As a result of the complications, Taylor’s doctor determined that the BioZorb had to be removed, requiring an unplanned mastectomy.

Kresch received her implant in October 2020, after she was diagnosed with ductal carcinoma in situ of the right breast. Following the surgery, Kresch developed a large abscess and a wound that refused to close for more than a year, resulting in multiple staph infections. Eventually a fragment of the broken BioZorb implant pierced through her skin. After removing that fragment, the rest of the BioZorb was surgically removed in June 2022.

For the defense picks, Hologic selected lawsuits filed by Beth Deuel and Pamela Gibson, which were brought on two other multi-plaintiff lawsuit filings.

The lawsuit including Deuel’s claims (PDF) was filed in March 2023, indicating that the Michigan woman was diagnosed with right breast invasive lobular carcinoma in May 2018, and was then implanted with a BioZorb during a lumpectomy. However, the device stuck out of her chest, resulting in searing pain, making hugs and even sleeping difficult activities to endure. 

After experiencing the problems, Deuel contacted Hologic, who told her everything was fine and the implant would dissolve in two years. Three years later, after it became clear the breast tissue marker was not dissolving, she had the implant surgically removed.

The complaint (PDF) that includes Gibson’s claim was also filed in March 2023. It indicates Gibson, of Colorado, was diagnosed with right breast cancer and underwent a right partial mastectomy in June 2020, resulting in pain, a hard lump, deformity, scarring and other problems indicative of BioZorb complications. 

At the time of the filing, Gibson’s breast tissue marker had not yet been removed, and she indicated at that time that it was continuing to cause difficulty sleeping due to the pain and discomfort.

BioZorb Bellwether Lawsuits On Track

In the report submitted last week, the lawyers also updated Judge Burroughs on the status of preparations to get each of the cases ready to go before a jury.

“The Parties are accordingly on track to complete case-specific fact discovery for the first two bellwether trials by the May 27, 2025 deadline,” the report states.

In February, Judge Burroughs called for the first BioZorb bellwether trial to begin on September 8, 2025, with a second trial set to begin on January 20, 2026.

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 negotiations needed to avoid each claim ultimately being set for trial in the future.