What is BioZorb?

The BioZorb litigation is shaping up to be one of the most significant legal challenges of 2025, presenting a unique opportunity for plaintiff attorneys nationwide. This case revolves around a medical device designed to aid breast cancer patients but has since been linked to serious complications, sparking widespread litigation. As the legal landscape evolves, understanding the intricacies of this litigation—including the potential for multidistrict litigation (MDL), the growing plaintiff pool, and the judicial approach—will be critical for attorneys looking to advocate for affected clients effectively.

BioZorb is a bioabsorbable marker device used in breast cancer surgeries, particularly lumpectomies and partial mastectomies. Its primary purpose is to provide structural support to the breast after tumor removal, aiding in radiation therapy by maintaining the tissue’s shape. The device is made from a polymer that gradually dissolves in the body, eliminating the need for surgical removal.

A standout feature of BioZorb is its radiopaque markers, which are designed to help radiologists precisely target the treatment area during follow-up radiation therapy. This precision is intended to minimize damage to healthy tissue and improve cosmetic outcomes. Marketed as a less invasive alternative to traditional surgical methods, BioZorb was initially hailed as a breakthrough for breast cancer patients. However, reports of severe complications—including infections, device migration, and even cancer recurrence—have cast a shadow over its safety and efficacy, leading to a surge in lawsuits.

The FDA Recall and Escalating Legal Scrutiny

On May 1, 2024, the U.S. Food and Drug Administration (FDA) issued a Class I recall for BioZorb, the agency’s most severe recall category. This classification is reserved for devices that pose a risk of serious injury or death, signaling a significant turning point in the litigation. The recall has heightened awareness among patients and healthcare providers, prompting many affected individuals to seek legal recourse.

For plaintiff attorneys, this recall underscores the gravity of the allegations against BioZorb’s manufacturer, Hologic, Inc. It also serves as a critical piece of evidence in establishing liability, as it highlights the FDA’s concerns about the device’s safety and regulatory compliance.

Current Judicial Proceedings

As of now, the BioZorb lawsuits are being consolidated in the U.S. District Court for the District of Massachusetts under Judge Allison D. Burroughs. While no MDL has been formally established, the growing number of cases—over 100 plaintiffs and counting—makes consolidation a likely next step. Centralizing these cases would streamline pretrial proceedings, reduce duplicative discovery, and create a more efficient path toward resolution.

Judge Burroughs has implemented a “bellwether” trial plan, which involves selecting a small group of representative cases to be tried first. These trials, scheduled to begin in September 2025, will serve as a litmus test for how juries respond to evidence of BioZorb’s alleged design defects. The outcomes of these early trials could set the tone for future settlements or verdicts, making them a pivotal moment in the litigation.

In a significant win for plaintiffs, Judge Burroughs denied Hologic’s motion for summary judgment on January 16, 2025. This ruling allows the cases to move forward and signals that the court is taking the plaintiffs’ claims seriously.

The Expanding Plaintiff Pool

The potential plaintiff pool in the BioZorb litigation is vast. Since its FDA approval in 2012, BioZorb has been used in thousands of breast cancer surgeries across the United States. Women who have experienced complications such as infections, chronic pain, disfigurement, or cancer recurrence after receiving the device may be eligible to file claims.

The emotional and financial toll on these patients is substantial. Many have faced additional surgeries, prolonged medical treatments, and significant emotional distress. As media coverage of the litigation grows, more affected individuals are likely to come forward, further expanding the plaintiff pool.

Why This Litigation Matters

The BioZorb litigation is more than just a legal battle; it’s a fight for accountability and justice. For plaintiff attorneys, this case represents an opportunity to hold a major medical device manufacturer accountable for alleged negligence and defective design. It also offers the potential for significant financial recovery for clients who have suffered due to the device’s complications.

From a strategic perspective, the litigation aligns with broader trends in medical device liability, where plaintiffs are increasingly challenging the safety and efficacy of widely used products. Staying ahead of these trends and understanding the nuances of the BioZorb case will be essential for attorneys aiming to build strong, compelling claims.

The Role of Media and Public Awareness

Media coverage has played a crucial role in raising awareness about the risks associated with BioZorb. Outlets like *The New York Times* and *Reuters* have reported on the FDA recall and the growing litigation, bringing the issue to the forefront of public consciousness. For example, a recent *Reuters* article highlighted the FDA’s concerns and the potential for widespread legal action, while *The New York Times* explored the personal stories of women affected by the device. These stories not only inform potential plaintiffs but also underscore the human impact of the litigation.

Conclusion

The BioZorb litigation is poised to become a landmark case in medical device liability, offering plaintiff attorneys a chance to make a meaningful impact while pursuing justice for their clients. With a potentially massive plaintiff pool, the likelihood of MDL formation, and the prospect of significant settlements or verdicts, this case demands attention and strategic action.

As the legal proceedings unfold, staying informed about developments in the courtroom, emerging trends in medical device litigation, and the evolving plaintiff pool will be critical. For attorneys willing to invest the time and resources, the BioZorb litigation represents not only a chance to advocate for injured clients but also a viable business opportunity in a rapidly growing area of law.

The Best Case Leads Advantage

At Best Case Leads, we understand what matters most to plaintiff attorneys: cost-effective, high-quality case leads. Our approach sets us apart:

– **Advanced Fraud Detection:** Our rigorous screening process ensures that only legitimate, compensable cases reach your desk.

– **Comprehensive Medical Records:** We provide detailed medical documentation to support your cases.

– **Non-Incentivized Intake Agents:** Unlike other firms, our agents are not incentivized to sign unqualified claimants, ensuring the integrity of your leads.

– **Attorney-Level Interviews:** We conduct in-depth, open-ended interviews to gather critical information, just as an attorney would.

By partnering with Best Case Leads, you can focus on building strong cases while we handle the groundwork. Let us help you navigate the complexities of the BioZorb litigation and secure the justice your clients deserve.

For further reading on the BioZorb litigation, check out these articles:

– [Reuters: FDA Issues Class I Recall for BioZorb Device](https://www.reuters.com)

– [The New York Times: Breast Cancer Patients Face New Challenges with BioZorb Complications](https://www.nytimes.com)

– [Law360: BioZorb Litigation Heats Up as Judge Denies Summary Judgment](https://www.law360.com)