Understanding the BioZorb Litigation: A Guide for Plaintiff Lawyers

The BioZorb litigation offers a significant opportunity for plaintiff lawyers. As we consider their involvement in this case, it is crucial to consider the intricacies of the litigation, the potential plaintiff pool, the possibility of an MDL, and the approach of the currently presiding judge. This litigation might just be the first big case of 2025 for plaintiff lawyers - nationwide.

What is BioZorb?

BioZorb is a bioabsorbable device used in breast cancer surgeries to provide shape and support to the breast post-tumor removal, making radiation therapy easier. Made from a bioabsorbable polymer, BioZorb gradually breaks down in the body, allowing natural healing and eliminating the need for a second surgery to remove the device.

A key feature of BioZorb is its embedded radiopaque markers, which assist in imaging during follow-up radiation therapy. These markers are supposed to enable precise targeting of the treatment area, reducing the risk of damage to surrounding healthy tissue. Marketed as a less invasive alternative to traditional procedures, BioZorb claims to reduce complications and improve cosmetic outcomes. However, reports of adverse outcomes have raised concerns within the medical community and led to litigation.

Current Judicial Proceedings

On May 1, 2024, the FDA issued a Class I recall for BioZorb, the most severe category, reserved for situations where use of a device can cause serious injury or death. This classification served as a stark warning to both medical professionals and patients, further escalating scrutiny of the device's design and regulatory compliance.

Currently, there is no MDL for BioZorb cases, but this may change soon. While no Motion has been made to the JPML yet, this is a case where consolidation simply makes sense. With over 100 plaintiffs already involved and the potential for many more, centralizing these cases would certainly streamline pretrial proceedings. For now, the BioZorb lawsuits are still being consolidated in the U.S. District Court for the District of Massachusetts and are progressing under a "bellwether" plan established by Judge Allison D. Burroughs. This plan involves selecting a small group of representative cases for early trials to gauge how juries respond to evidence that the BioZorb tissue marker was defectively designed. These trials will provide insights into liability and potential BioZorb settlement amounts. The parties have proposed a random selection process to determine the trial order. Trials are expected to last approximately three weeks each, with the first trial scheduled for September 8, 2025, and the second in January 2026.

On January 16, 2025, Judge Burroughs denied Hologic's motion for summary judgment about risks associated with BioZorb. This is a significant win for plaintiffs and a sign that this case is about to grow, quickly. If and when the litigation is centralized as an MDL, the Massachusetts District Court is a strong candidate to host because Hologic, Inc., the manufacturer, is headquartered there. In addition, most cases are already filed there.

The Plaintiff Pool

The potential plaintiff pool in BioZorb litigation is substantial, likely to be in the thousands of plaintiffs. BioZorb has been used in lumpectomies and partial mastectomies since its FDA approval in 2012, meaning a large number of breast cancer patients may have received the device over more than a decade. Any woman that has undergone breast cancer surgeries with BioZorb and experienced complications—such as infections, poor cosmetic results, or recurrence of cancer—could be eligible to file claims. These complications can significantly impact their quality of life, leading to medical expenses, further surgeries, and emotional distress. As awareness of the risks associated with BioZorb increases through media coverage, more individuals may come forward with claims, potentially expanding the plaintiff pool.

Conclusion

The BioZorb litigation represents a unique opportunity for plaintiff lawyers to engage in a growing area of medical device liability. With a potentially large plaintiff pool, the prospect of MDL formation, and the possibility of significant financial recovery, the case merits serious consideration.

As the litigation progresses, staying informed about judicial proceedings and emerging trends will be crucial for plaintiff lawyers looking to navigate this complex landscape effectively.

Investing in BioZorb litigation not only aligns with the mission of seeking justice for injured clients but also presents a viable business opportunity for attorneys. As the legal landscape evolves, those who act decisively may well reap the benefits of their foresight.

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Craig H. Alinder, Vice President

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