Judge Clears BioZorb Breast Marker Lawsuit To Move Forward, Rejecting Motion for Summary Judgment

The U.S. District Judge presiding over all BioZorb breast marker lawsuits being pursued in the federal court system has rejected a motion filed by the manufacturer to have one of the cases dismissed, in a ruling likely to have wide impact throughout the litigation.

The BioZorb Marker is a small implant approved for use among breast cancer survivors and other individuals who require targeted radiation therapy. It consists 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, in late October, the U.S. Food and Drug Administration (FDA) reported that Hologic, Inc. was removing all BioZorb implants from the market due to the increased risks of pain, infection, rash, device migration, erosion and other complications. Last month, the agency announced it was giving the BioZorb recall a Class I designation, the most serious classification of recall, removing all remaining models from the market.

Hologic now faces more than 80 BioZorb lawsuits over the breast marker brought by women who indicate that the device migrated, fractured or caused other injuries. The cases are consolidated before U.S. District Judge Allison Burroughs in the District of Massachusetts, where the manufacturer’s U.S. headquarters are located.

In November, Hologic filed a motion for summary judgment, seeking to dismiss a product liability lawsuit filed by Joyce Rishell, who indicates she suffered a variety of injuries after being implanted with a BioZorb breast marker during her cancer treatment.

After the BioZorb Marker was placed in her breast, Rishell developed pain at the surgical site, felt the device pressing against her skin from the inside, and detected a wound forming in the affected area.

As a result of the complications, doctors surgically removed the device in August 2022, only a few months after it was implanted, when they determined she had an infection at the surgical site and that the device “was physically breaking through her skin and protruding from her breast.”

In its motion for summary judgment, Hologic claimed that Rishell’s lawsuit failed to name an actual defect or specific design problem with the tissue marker, which should preclude her from making design defect claims. The company also claims that nearly all of the other lawsuits fail to meet the requirements for design defect claims, based on where the plaintiffs live.

However, in a memorandum and order (PDF) issued on January 3, Judge Burroughs rejected Hologic’s argument and noted that Rishell’s claim was one of more than 80 making similar allegations against the company, suggesting her opinion will be widely applied to all of them.

Judge Burroughs denied the company’s attempt to dismiss Rishell’s failure to warn, negligent design and negligence claims, but did dismiss a claim of Breach of Implied Warranty of Merchantability.

The decision means the BioZorb Breast Marker lawsuit can move forward, and suggests that Hologic’s attempts to dismiss similar claims will also fail.

January 2025 BioZorb Lawsuits Update

As part of the coordinated pretrial proceedings in the BioZorb litigation, 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 were expected to be completed last month.

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, and 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.