Titanium Breast Marker Lawsuit

The BioZorb Marker is an implantable radiographic marker device designed to be used in soft tissue sites — notably in breast-conserving surgery (e.g., lumpectomy) to mark the surgical site for subsequent imaging or radiation therapy. The device consists of two main components: a bio-absorbable polymer spiral meant to be resorbed by the body over one year or more, and a set of small permanent titanium clips that remain as markers in the tissue.

The manufacturer is Hologic, Inc. (which acquired the original developer, Focal Therapeutics). The FDA issued a Class I recall of all unused units of BioZorb Marker and BioZorb LP Marker in October 2024 — this being the most serious type of recall, indicating a “reasonable probability that use of the device will cause serious adverse health consequences or death.”

According to the FDA safety communication and recall notice, reported complications included device migration (movement), device erosion (protrusion through the skin), fluid buildup (seroma), infection, pain and discomfort, and other adverse events.

What Are the Allegations in the Lawsuits?

The lawsuits against Hologic (and implicating the BioZorb Marker device) generally assert the following claims:

1. Defective design – Plaintiffs claim that the device’s design (bio-absorbable polymer spiral + titanium clips) is inherently unsafe or was not adequately tested for long-term performance in breast tissue, such that the expected resorption/fate of the material was misrepresented or flawed.
2. Failure to warn (inadequate labeling/marketing) – It is alleged that Hologic did not sufficiently warn surgeons or patients of the risks of migration, long-term residual marker, erosion through skin, pain or the need for removal. The marketing of BioZorb is also alleged to have promoted uses (such as cosmetic tissue-filling) for which FDA clearance was not given.
3. Negligence / breach of warranty – Plaintiffs argue that Hologic had a duty to ensure the device was safe for its intended use and to monitor post-market performance, but failed in those duties.
4. Regulatory and manufacturing lapses – Some complaints include allegations of insufficient clinical data, inadequate adverse event reporting, or manufacturing control issues. For example, Hologic received a FDA warning letter citing shortcomings in quality control and adverse-event reporting.

Thus, the legal basis is typical of medical device product-liability: design defect, failure to warn, manufacturing defect (where applicable), and negligence.

Litigation Status & Key Developments

• As of 2024-25, more than 100 individual lawsuits have been filed by patients who received a BioZorb implant and later experienced complications. Some reports put “over 120” or “nearly 400” complaints.
• The FDA’s recall on October 24, 2024 of all unused BioZorb Marker devices followed by the safety communication “Do Not Use” marked a significant regulatory trigger.
• The litigation is moving toward the bellwether stage: a group of cases selected as representative for early trials is being developed in the U.S. District Court for the District of Massachusetts (presided over by Judge Allison D. Burroughs). For example, in August 2025 reports indicate initial trial dates set for early 2026.
• A key ruling: On September 28, 2024, the Court denied Hologic’s motion to dismiss summary judgment in a case, finding the plaintiff sufficiently alleged that a warning could have changed physician behavior.
• Though the lawsuits are consolidated in case‐management (bellwether) fashion, they appear to not yet be part of a formal multidistrict litigation (MDL) or class action.

Why It Matters

For Patients

Breast-cancer patients who undergo lumpectomy or partial mastectomy and have a device like BioZorb implanted expect the marker to assist their treatment and afterwards to pose no additional risk. When instead the device causes pain, migration, revision surgery, or cosmetic disfigurement, the impact is significant: additional surgeries, infection risk, delayed cancer therapy, emotional/psychological harm.

For Healthcare Providers

Surgeons and radiation oncologists must consider device safety and informed consent: if a device carries a known risk (or one that becomes known), patients must be informed. The marketing of the device for off-label uses (e.g., cosmetic filling rather than solely marking tissue) raises concerns about physician awareness of true risk profile.

For Medical Device Manufacturers

This case drives home the importance of thorough pre-market testing and ongoing post-market surveillance for implantable devices. The clearance process via FDA 510(k) requires demonstration of “substantial equivalence” but may not always require new clinical trials; when devices are innovative (e.g., new coil plus titanium marker), risk of latent failures must be managed. The regulatory and litigation stakes are high.

For the Legal Landscape

The BioZorb Marker litigation exemplifies a trend: implantable devices that are newer, combined biomaterial/metals, and often used in cancer treatment settings can become the subject of mass or multi‐plaintiff litigation. The fact that the recall and safety communication preceded large verdicts means settlement pressure may rise.

Key Legal Considerations & Challenges

• Causation: Plaintiffs must show that their injuries (migration, erosion, infection, pain, surgery) were caused by the BioZorb Marker rather than unrelated factors (e.g., previous surgery, radiation therapy, individual patient variation).
• Pre-existing condition/competing hazard: Many patients have undergone breast surgery, radiation therapy, chemotherapy—so differentiating device harm vs treatment side-effects is complex.
• Design versus labeling: Manufacturers will defend that the device performed as designed and approved; plaintiffs’ best claims may be failure to warn or misleading marketing rather than pure design defect.
• Statute of limitations: Each state has different time limits for filing product-liability claims; patients must act before those deadlines expire.
• Settlement dynamics: With bellwether trials upcoming, parties may negotiate early settlements; but without a large public settlement yet, case values are speculative.
• No class action/MDL (yet): The absence of a formal class or MDL means each plaintiff’s circumstances remain individualized, possibly slowing resolution and making outcomes more variable.

Looking Ahead

As the first bellwether trials are scheduled for 2026, plaintiffs and defendants will use those outcomes to evaluate settlement strategies. If juries favour plaintiffs and award significant damages, Hologic may choose a large resolution. If not, the litigation may continue for years, with each case litigated individually (albeit under coordinated case‐management).

Potential claimants (patients who received a BioZorb Marker and later suffered complications) should consult experienced medical‐device attorneys, gather their surgical/radiation/treatment history, documentation of the implant, adverse events, and revise timelines carefully.

From a broader viewpoint, this litigation underscores the importance of device safety, the role of titanium/metal markers in implants, and the potential for long-tail adverse events even in “low-risk” implants.