BioZORB Litigation Ruling: A Turning Point in Medical Device Safety

The recent ruling in the BioZORB litigation has highlighted both the growing concern AND the legitimacy of lawsuits surrounding the use of the BioZorb marker in breast cancer treatment. BioZorb lawsuits are consolidated in Massachusetts federal court. Over 80 plaintiffs filed lawsuits claiming that the BioZORB device caused them severe pain, complications, and unnecessary surgical interventions.

The U.S. District Court in Massachusetts has allowed these claims to move forward. In most cases, the Court found that implanting physician testimony has confirmed sufficient evidence exists that surgeons did not receive adequate warnings about the risks of the product.  This means that, for most of these plaintiffs, when their case is tried, the jury will be presented with evidence that the manufacturer of BioZorb failed to warn the medical community of known dangers that the company knew or should have known, yet failed to warn.  This signals a pivotal positive movement in the litigation. To read the full opinion, click HERE. 

The Role of BioZORB in Cancer Treatment

BioZorb is a medical device developed by Hologic, Inc. to assist in post-lumpectomy radiation treatment for breast cancer patients. The device, which the FDA classified as a Class II medical device, is a spiral-shaped bioabsorbable spacer that holds six titanium clips. These clips are meant to mark the surgical site, helping to guide precise radiation therapy. Hologic markets the BioZorb as a device that dissolves into the body in approximately 1 year, supposedly reducing the risk of complications after cancer surgery.

However, many patients have experienced issues long after the BioZorb was implanted. Some reported persistent pain, others described the device becoming palpable under their skin, and some even have undergone additional surgeries to remove the device after it failed to resorb, protruded through their skin, or resulted in a chronic, hardened, painful lump. According to the lawsuits, these problems arose because the BioZorb did not dissolve as promised, or caused other unforeseen complications, such as scarring, infections, or lump formations.

The Legal Battle: Failure to Warn and Negligent Design

Central to the lawsuits is the claim that Hologic failed to adequately warn doctors and patients about the true risks of the BioZorb device. Plaintiffs like Rita Melkonian, Tricia Willard, and Karen Ensley argued that they were told the device would dissolve within a year. But years after their surgeries, the device had not fully absorbed, leaving them in pain and with other medical complications. Some doctors even testified that they would have reconsidered using BioZorb if they had been given adequate warnings about its long-term effects.

The ruling sheds light on the learned intermediary doctrine, which typically shields medical device manufacturers from direct liability if they provide adequate warnings to doctors. Under this doctrine, the physician acts as the intermediary between the patient and the manufacturer, and the duty to warn rests with the doctor. However, in this case, the court found that Hologic’s warnings might not have been sufficient for doctors to make fully informed decisions. The plaintiffs’ doctors, in some instances, testified that they were unaware of the risks associated with the device or were misled about its resorption timeline. As a result, the court allowed the **failure-to-warn** claims from several plaintiffs to proceed.

BioZORB’s Dangerous Consequences

The ruling highlights the potential dangers of using BioZorb, as described by patients and their doctors. The device’s failure to dissolve as expected has led to pain, scarring, and the development of lumps that many patients feared were signs of cancer recurrence. In some cases, patients had to undergo additional surgeries or other treatments to address the complications caused by the device.

Plaintiffs testified to long-term suffering and distress caused by the BioZorb device. One developed a painful lump shortly after her surgery and, despite seeking multiple opinions, was advised to wait for the device to dissolve. However, the lump persisted for over two years, significantly longer than the device’s marketed dissolution timeline. In another  case, the device caused tenderness and pain near the surgical scar, making even light touches unbearable. Despite these experiences, Hologic’s warnings failed to address the risks of prolonged pain, device migration, or incomplete absorption.

What This Means for Future Medical Device Litigation

This ruling could have broader implications for **medical device safety,** particularly for medical devices where there are virtually no warnings contained within the device’s label that warns doctors about the likelihood, degree, or severity of potential adverse effects. It suggests that manufacturers must provide more thorough warnings about the risks of their products, especially when dealing with patients who are already in vulnerable positions. For the plaintiffs involved, this ruling represents a significant step forward in holding Hologic accountable for the harm caused by BioZorb. It also raises awareness of the potential risks associated with bioabsorbable medical devices, pushing for better and more clear warnings surrounding the risks of medical devices, and more transparency in the marketing of such products.

Investigating BioZorb Cases

At KBA Attorneys, we are litigating BioZorb cases. We file lawsuits to help patients who have suffered from complications related to this device. If you or a loved one experienced pain, scarring, or other complications after a BioZorb implant, our legal team is here to assist. We are committed to fighting for your rights and ensuring you receive the compensation you deserve. Contact us today for a free consultation.