Judge Indicates BioZorb Recall and Warning Letter Do Not Warrant Reopening Discovery in Bellwether Cases

Plaintiffs sought to conduct additional discovery and depositions, as a small group of BioZorb recall lawsuits are being prepared for early trial dates expected to begin in September 2025.

The U.S. District Judge presiding over all federal BioZorb lawsuits has denied a request by plaintiffs to reopen the discovery and deposition process in a small group of “bellwether” cases previously selected for early trial dates, even thought the manufacturer decided to recall the tissue marker late last year.

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

Although 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, women have been complaining for years about continuing pain, discomfort and other complications that persisted long after receiving the implant, often resulting in the need for the BioZorb marker to be surgically removed.

Following years of complaints raised by patients and medical providers, the manufacturer finally agreed to issue a BioZorb marker recall in October 2024, and the FDA recently sent a warning letter outlining manufacturing problems discovered during an inspection of the company’s facility in Massachusetts.

However, even prior to the recall, a steadily growing number of product liability lawsuits have been filed against the manufacturer, Hologic, Inc., each raising similar allegations that the company failed to warn about the device failing to dissolve, resulting in injuries and the need for surgical removal.

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.

Although the outcome of these bellwether trials will not have any binding impact on other claims, they are being closely watched to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation. The average jury payouts awarded may also have an impact on eventual BioZorb settlement negotiations needed to avoid each individual case going before a jury in the future.

Bellwether BioZorb Trials Will Stay on Track After Recall, Warnings

In July 2024, Judge Burroughs directed 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 over the past nine months, to help the parties gather information to select a smaller group of cases to present to juries as early test cases.

Late last year, the parties whittled that list down to four bellwether trial candidates. Judge Burroughs announced that the first BioZorb lawsuit bellwether trial will begin on September 8, 2025, with a second trial set to begin on January 20, 2026.

In a text-only docket entry issued on February 3, Judge Burroughs revealed that some plaintiffs had asked to re-open the discovery process in a motion late last month, calling for new depositions regarding the BioZorb recall, which came after much of the work on prepping the bellwether trials was already completed.

However, Judge Burroughs rejected the proposal, indicating she could not see how interviewing plaintiffs’ physicians on a recall that happened months or years afterwards would be relevant to the litigation.

“These depositions took place in early 2024,” the judge noted. “Each party agreed to accept the risks and rewards of early discovery, briefing and resolution concerning the learned-intermediary doctrine.”

Judge Burroughs indicated that the plaintiffs’ motion was untimely, coming three months after the recall was issued, and after the court has already set a schedule for the bellwether trials.

Therefore, the start of the bellwether trials is expected to remain on track, and any additional discovery related to the BioZorb recall and warnings will be limited to future trial selections.