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Important Victory for Patients in BioZorb Medical Device Litigation

  • January 21, 2025
  • KBA Attorneys
  • No Comments

Important Victory for Patients in BioZorb Medical Device Litigation

There are now nearly 100 cases filed in federal court in the District of Massachusetts, and hundreds more are expected to be filed in the coming months, as women have come forward to report that they have experienced excruciating breast biopsy marker side effects after receiving a recalled BioZorb breast implant marker.  

BioZorb titanium marker is an implantable medical device manufactured by a Massachusetts-based pharmaceutical company, Hologic, Inc.  It is mostly used in breast cancer surgery to mark the tumor removal site for radiation treatment. The device consists of a spiral-shaped frame that’s supposed to dissolve over time, leaving behind only small titanium clips to guide radiation therapy.  However, what experts are now discovering is that the material that makes up the “spiral-shaped” implant design has several defects and promotes an inflammatory reaction in patients.  In many patients, not only does the design fail to dissolve as intended, but it also leaves behind a painful inflamed tumor-like “mass” in the recipient’s breast that hangs around years after implantation.  Some patients report having a BioZorb “mass in their breast 4 or more years after it was supposed to dissolve.

Most women report that they were told very little, if any, negative side effects about the BioZorb breast biopsy marker.  Several women report that they were not told that they had other surgical options or otherwise received no notice that the BioZorb implant was associated with significant breast biopsy marker side effects.

KBA and other attorneys blame this widespread misinformation in large part to the manufacturer’s lack of reporting problems to the FDA, an issue that the FDA laid out in a stern warning letter dated December 18, 2024. 

Lawyers have been on top of these issues long before the FDA.  In fact, the first lawsuit alleging that BioZorb failed to warn of breast biopsy marker adverse side effects and was defectively designed is now over two years old.  This suit and others are progressing along in federal court in the District of Massachusetts.  In a recent significant win for patients, the judge in Massachusetts has denied medical device manufacturer Hologic’s attempt to dismiss a key case in the ongoing BioZorb titanium marker litigation. This January 2025 ruling allows injury claims against Hologic to move forward to trial.


Why This BioZorb Medical Device Ruling Matters


The court rejected Hologic’s argument that they could not be held responsible for injuries because they only had a duty to warn doctors, not patients, about potential risks (known as the “learned intermediary doctrine”). Instead, the judge found sufficient evidence that:

1) Doctors were not adequately warned about how long the Biozorb implant could take to dissolve.

2) The surgeon in this case testified he stopped using BioZorb after discovering it wasn’t dissolving as quickly as the company had claimed.

3) If proper warnings had been provided earlier, the doctor may have chosen not to use a Biozorb marker.

What This Means for Patients


If you’ve experienced complications from a BioZorb implant, this ruling helps protect your right to seek compensation. The court’s decision allows claims to proceed related to:

  • Failure to warn about risks
  • Design defects in the device
  • Breach of warranty
  • General negligence

Our firm continues to advocate for patients injured by BioZorb markers. Lawyer Robert Price is KBA’s lead lawyer for the BioZorb litigation and is one of the nation’s lead lawyers in BioZorb litigation centralized in Massachusetts. Robert is currently working with nationwide experts to get ready for trial against the manufacturer of BioZorb.  The Massachusetts judge has set trials beginning in September 2025.  These “bellwether” trials are designed to set the pace for future cases and, if successful, will illustrate to the manufacturer that BioZorb marker victims deserve compensation for being implanted with a defective recalled device.

We understand the physical and emotional toll these complications can take. If you or a loved one has experienced issues with a BioZorb titanium marker, contact us for a free consultation to discuss your legal rights, including filing a BioZorb lawsuit.

The fight for justice in the BioZorb litigation is ongoing, but this ruling represents an important step forward for patients. We remain committed to holding manufacturers accountable and securing fair compensation for those who have been harmed.