Amended Lawsuit Over BioZorb Implant Side Effects Outlines Problems Caused By Tissue Marker Design Defects

Six breast cancer patients have filed a motion seeking leave to amend a BioZorb implant lawsuit originally brought in March, adding information about an FDA recall issued the following month, as well as allegations regarding design defects that caused each of them to suffer painful side effects when the device migrated out of position or shattered inside their bodies.

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

Although the BioZorb 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, a number of patients have reported experiencing painful complications when the devices failed to absorb back into the body.

As a result of these problems, the FDA announced a BioZorb recall in May 2024, and the manufacturer now faces dozens of product liability lawsuits involving allegations that the marker was defectively designed and failed to contain adequate warnings about the potential risk of BioZorb implant side effects.

Given similar allegations and claims presented in complaints filed against Hologic, Inc. in the U.S. District Court for the District of Massachusetts, where the manufacturer’s headquarters are located, all lawsuits over BioZorb implants have been consolidated before U.S. District Judge Allison D. Burroughs for coordinated discovery and pretrial proceedings.

Earlier this year, Judge Burroughs established a “bellwether” program, where the parties selected a small group of representative claims to go through early motions and case-specific discovery. As part of that process, Hologic filed a motion for summary judgment in several of these bellwether claims, based on the learned intermediary doctrine. However, the manufacturer also contended that plaintiffs failed to adequately plead their design defect claims.

In response to this motion, several plaintiffs with early filed lawsuits have sought to amend their original complaints, providing additional details in support of their design defect claims, and adding information about the more recent FDA BioZorb recall announced in May 2024.

BioZorb Implants Cause Painful, Disfiguring Complications

On August 21, a group of six plaintiffs whose claims were not selected for the bellwether process filed a motion for leave to update their complaint (PDF), indicating that the amendments are unrelated to the learned intermediary issue, but will provide new facts concerning the recent recall, and how the BioZorb implant defects caused their injuries.

In the proposed new complaint (PDF), plaintiffs Shellie Broeder, Amy Delgado, Marisa Sayers, Michelle Martinez and Anita Mendiola each outline the painful and sometimes disfiguring complications experienced when their BioZorb implant failed.

Broeder, of Montana, indicates that she was implanted with a BioZorb Marker in October 2022, after she was diagnosed with breast cancer. Following the procedure, she developed a hard, painful lump at the implant site. Whenever she moved, the pain worsened, causing her extreme emotional distress due to the similarities to a breast cancer tumor.

Doctors eventually decided to remove the implant as the pain continued to worsen, discovering it had migrated out of position, not only causing a disfiguring scar, but failing to have done what it was supposed to do: mark the specific location of a recent tumor removal surgery.

Sayers, of Michigan, indicates that she was diagnosed with breast cancer in 2018, and received her BioZorb implant as part of a lumpectomy procedure. However, design defects allegedly caused her BioZorb to shatter inside of her body, causing severe pain and numerous complications.

“Ms. Sayers suffered from unrelenting and excruciating pain at and around the site of the BioZorb Marker. Plaintiff Sayers suffered from a stabbing sensation and severe discomfort that affected her daily life, making it difficult to lay down or perform daily activities,” the amended complaint states. “The BioZorb fractured into pieces and migrated in her breast, intensifying the pain she had to endure until the removal of the device.”

The complaint indicates that the risk of BioZorb side effects, such as “fracture, migration, adverse local tissue reaction, disfigurement, nonabsorption, palpable mass, and additional surgery”, are not adequately designated on the marker’s warning labels, even though the manufacturer knew those risks existed, the plaintiffs argue.

Bellwether BioZorb Side Effects Lawsuit Preparations

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 will go through depositions, exchange of medical records and other case-specific discovery, which must be completed by December 16, 2024.

After discovery is complete in the bellwether BioZorb side effects lawsuits, each side will be able to strike three cases from the pool, leaving a total of four claims that will be eligible to go before the first juries in or around July 2025.

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