BioZorb Lawsuit

This page provides a comprehensive overview of the BioZorb lawsuit and the potential legal and financial implications for plaintiffs who have suffered due to this medical device.

The FDA classified Hologic’s notification to healthcare providers as a Class I recall, indicating a serious risk of injury or death. This recall highlighted numerous complications, including device migration, infection, and other adverse reactions.

The BioZorb implant, designed as a post-lumpectomy tissue marker for breast cancer patients, has been associated with severe complications, including chronic pain, scarring, and the need for additional surgeries. Despite its promise to aid recovery, the device has led to outcomes not fully disclosed by its manufacturer, Hologic.

Our lawyers will delve into the background of Biozord’s titanium breast markers, the legal allegations surrounding its use, and how our attorneys will make way-too-early predictions of possible BioZorb settlement amounts and jury payouts.

If you suffered complications related to a BioZorb implant device, you want to act quickly.  Call our attorneys today at 800-553-8082 or contact us online. There is no cost to you unless you get compensation for the harm done to you.

2025 BioZorb Lawsuit Update

The BioZorb Marker lawsuits continue to evolve quickly in a very short time.

February 21, 2025:  Trial Date

Judge Allison Burroughs has scheduled the BioZorb trial for September 8, 2025. That trial will help set titanium breast marker lawsuit settlement amounts assuming there is not a global settlement before that trial.

February 13, 2025: No New Discovery

Plaintiffs’ attorneys for BioZorb victims filed a motion late last month requesting to reopen discovery, seeking new depositions related to the BioZorb recall, which occurred after most of the bellwether trial preparations had been completed.  In a terse order, the court rejected that request, saying there was no relevance in interviewing plaintiffs’ physicians about a recall that occurred months or years after the fact.

January 29, 2025: FDA Warning Letter

The FDA’s new BioZorb warning letter increases the concerns for patients implanted with this device. It also futher supports the claims in the growing BioZorb litigation against its manufacturer.
he FDA found that BioZorb’s design and manufacturing processes failed to meet basic safety and quality standards, including a lack of adequate testing to confirm that the device properly resorbs in the body as intended. This tracks with what we have seen in BioZorb lawsuits—patients reporting severe complications such as chronic pain, infection, tissue damage, and the need for surgical removal of the device years after implantation.
The FDA’s inspection also revealed that Hologic failed to properly account for how the device might interfere with cancer detection or respond to radiation treatments. Obviously, these are two critical issues for the breast cancer patients for whom BioZorb was heavily marketed. These failures, combined with a spike in reported adverse events in 2023, make it clear that the manufacturer knew full well of the serious risks with BioZorb but failed to act.

For plaintiffs, this FDA warning letter strengthens claims that Hologic negligently designed and marketed BioZorb without properly assessing its long-term safety. The fact that the FDA concluded Hologic’s response was inadequate, even after the company announced it would discontinue BioZorb, gives real punch to the argument that the device never should have been sold in the first place.

The FDA also cited Hologic for failing to report serious adverse events within the legally required timeframe. So it is hardly a stretch to question how long the company concealed evidence of BioZorb’s dangers from doctors and patients.

January 16, 2025: Big Win for Plaintiffs

Judge  Burroughs denied Hologic’s motion for summary judgment in a case involving allegations that the company failed to adequately warn a surgeon about risks associated with its BioZorb radiographic marking device.

The plaintiff, a South Carolina resident, claims that the device caused severe complications requiring multiple surgeries due to inadequate warnings about its performance. She underwent a partial mastectomy in 2020, during which her surgeon implanted the BioZorb device to mark the excision site for radiology. A Hologic representative informed the surgeon that the device’s bioabsorbable material would resorb within six to twelve months, leaving only titanium clips for radiographic imaging. However, complications arose, including pain and an abscess, leading to multiple follow-up procedures to remove parts of the device. The plaintiff’s case is one of 22 consolidated lawsuits, with this case designated as part of the bellwether trial pool.

Hologic argued that the plaintiff failed to show that stronger warnings would have changed her surgeon’s decision to use BioZorb. The company highlighted deposition testimony suggesting the surgeon could not definitively state whether earlier knowledge of risks, including extended resorption times and adverse event reports, would have altered his treatment plan. So that was a concern in this case. But  Judge Burroughs made the right call, emphasizing evidence showing the surgeon’s eventual decision to stop using BioZorb entirely after discovering, through personal experience, that the device did not resorb as quickly as promised. The court concluded that a jury could reasonably infer that earlier warnings might have led the surgeon to avoid using the device in the plaintiff’s case.

In denying summary judgment, Judge Burroughs noted, “A reasonable jury could conclude that a warning from Hologic about [the risk of prolonged resorption] could have caused [the surgeon] not to use the device at all—including in this case.” This ruling paves the way for the plaintiff to present her claims at trial, highlighting potential shortcomings in Hologic’s risk communication and the broader implications for medical device manufacturers.

BioZorb Lawsuit FAQ – What You Need to Know

Is the BioZorb lawsuit the next big breast cancer medical device litigation?
Yes. The BioZorb lawsuit is shaping into a major product liability battle, much like previous lawsuits against defective breast implants and surgical mesh. Plaintiffs allege that the BioZorb marker causes severe complications, including chronic pain, infection, and migration. The litigation has already gained momentum, with cases consolidated in the U.S. District Court of Massachusetts.
Why is BioZorb facing a recall, and how does it impact my case?
The BioZorb recall was classified as a Class I recall, the FDA’s most serious designation, indicating a high risk of injury or death. Hologic, the manufacturer, failed to properly warn patients and doctors about the risks. If you suffered from BioZorb complications, this recall strengthens your case, showing the company knew the dangers but didn’t act in time.
Can I file a BioZorb implant lawsuit if I needed a second surgery?
Absolutely. Many plaintiffs in the BioZorb implant lawsuit had to undergo additional surgeries because the device failed to resorb, caused painful scarring, or migrated. If you required a second procedure to remove your BioZorb implant, you likely have a pretty strong claim. .
What are the biggest allegations against Hologic in the BioZorb lawsuit?
The Hologic lawsuit claims that the company:
– Failed to warn doctors and patients about BioZorb’s risks.
– Misled surgeons into believing the device would fully resorb in 6-12 months.
– Promoted off-label uses, such as tissue filling and cosmetic enhancement.
– Delayed reporting adverse events to the FDA.
These failures are central to the BioZorb recall lawsuit and could have significant legal and financial consequences for Hologic.
Did Hologic hide BioZorb‘s dangers from the public?
That’s a key question in the litigation. The BioZorb complications lawsuit argues that Hologic knew about the risks—significantly delayed resorption and migration—but aggressively marketed the device anyway. The FDA even cited Hologic for failing to report serious injuries in a timely manner. This loads the gun for punitive damages and, if a jury agrees, could lead to a huge verdict that will push BioZorb settlement amounts higher.
Are BioZorb claims part of a class action lawsuit?
Not quite. The cases are consolidated under one judge but there is no BioZorb class action lawsuit. Instead, these cases are coordinated while allowing plaintiffs to receive individualized compensation based on their injuries.
What kind of settlement payouts can plaintiffs expect in the BioZorb lawsuit?
While it’s early, experts predict BioZorb settlement amounts could range from $150,000 to $500,000 per plaintiff, depending on the severity of injuries. If juries award punitive damages—especially given Hologic’s failure to warn—some verdicts could, and most likely, exceed $1 million. We talk a great deal more about expected settlement payouts below.
Does the FDA’s new warning about BioZorb help my lawsuit?
Yes. The FDA recently issued a BioZorb recall notice, confirming that the device poses serious health risks. Is this evidence admissible at trial?  Probably not. But it changes the dynamic of the litigation.  It puts Hologic more on their heels.
Why are so many women suing over BioZorb breast markers?
The titanium breast marker lawsuit claims that BioZorb, marketed as a safe radiographic marker for breast cancer patients, actually caused more harm than good. Instead of aiding recovery, it led to:
– Chronic pain and inflammation
– Infections and abscesses
– Device migration
– Scarring and disfigurement
Women who trusted this device are now facing life-altering complications, and they’re holding Hologic accountable.
Did Hologic push BioZorb for cosmetic benefits that weren’t FDA-approved?
Yes, and this is a major issue in the BioZorb marker recall lawsuits. While the FDA cleared BioZorb as a radiographic marker, Hologic marketed it as a tissue filler, claiming it would improve breast shape after surgery. However, patients who believed these claims now face permanent scarring and painful masses.
How do I know if I qualify for a BioZorb lawsuit?
If you had a BioZorb implant after a lumpectomy or breast biopsy and experienced complications such as pain, migration, infection, or required revision surgery, you may be eligible. Even if your device hasn’t been removed yet, you could still have a valid claim based on potential long-term damage.
What’s the next big date in the BioZorb litigation?
The first BioZorb lawsuit trial is set for September 8, 2025, in the U.S. District Court of Massachusetts. This bellwether trial will help determine how strong the plaintiffs’ cases are and could push Hologic toward a settlement (although there is a real chance of settlement before a jury ever hears a case).  If you’re considering legal action, now is the time to act—waiting could limit your options.

More Biozorb Lawsuit Updates

December 29, 2024: Cases Moving Towards Trial

BioZorb titanium breast marker lawsuits are moving forward at an encouraging speed.  Judge Burroughs has initiated a bellwether process to prepare representative claims for early trial dates.

In July 2024, Judge Burroughs ordered both parties to select 10 BioZorb lawsuits for a Discovery Pool, with each side designating five cases. These cases have since undergone depositions, medical record exchanges, and other discovery to identify four cases for the initial bellwether trials.

Now, a proposed case management order identified the following four cases for the trial pool:

  1. Case 1 involves a plaintiff who underwent a lumpectomy in October 2020 during which a BioZorb marker was implanted. The plaintiff later experienced complications, including lymphedema, a persistent wound, recurring staph infections, and a broken piece of the marker protruding from the skin in 2022, requiring surgical removal.
  2. Case 2 involves a plaintiff who received a BioZorb implant during a lumpectomy in June 2021. The implant failed to absorb into the body, requiring a subsequent mastectomy to remove the device. This would seem to be a very strong claim.
  3. Case 3 involves a plaintiff who received a BioZorb implant in May 2018. The device caused severe pain and discomfort as it protruded from the chest, leading to its removal in May 2022.
  4. Case 4 involves a plaintiff who received a BioZorb marker in June 2020 and has since reported complications, including pain, scarring, fibrosis, and an inability to sleep comfortably. The implant has not yet been removed.

The parties have proposed a random selection process to determine the trial order by January 17, 2025. Trials are expected to last approximately three weeks each, with the first trial scheduled for September 8, 2025, and the second in January 2026.

December 19, 2024  – Recall Notice

The FDA updated the recall notice yesterday.

December 17, 2024: Five Plaintiff Lawsuit Filed

Five breast cancer survivors from Washington, Illinois, Maryland, and New York brought claims against Massachusetts-based Hologic, Inc., alleging injuries caused by the company’s BioZorb Marker. The plaintiffs, who underwent lumpectomies or partial mastectomies, report severe complications, including pain, infection, device migration, scarring, disfigurement, and emotional distress. These issues, they claim, required additional surgeries and caused permanent physical and psychological harm.

The lawsuit, filed in federal court in Massachusetts, asserts that Hologic failed to adequately warn patients and healthcare providers of the risks associated with BioZorb, including prolonged resorption times, migration, and increased radiation exposure. Additionally, the plaintiffs contend that the company promoted unapproved uses of the device, including improving cosmetic outcomes and aiding radiotherapy.  The plaintiffs seek compensatory and punitive damages for the harm they have suffered.

December 12, 2024: BioZorb Class Action Lawsuit

Next year, it is certain plaintiffs’ lawyers will see a Hologic BioZorb class action lawsuit or, more specifically, an MDL. While the terms “class action” and “MDL” are often used interchangeably, they are distinct legal mechanisms.

A class action consolidates claims into one lawsuit with a single trial, representing all class members as a unified group. In contrast, a multidistrict litigation (MDL) centralizes individual cases before one court for pretrial proceedings, such as discovery and motions, but each case retains its individuality and can proceed to separate trials. MDLs are often used in product liability cases like BioZorb because the claims share common questions of fact, but the damages and circumstances vary significantly for each plaintiff, requiring individual trials or settlements. This distinction is crucial, though it is frequently misunderstood, even by those following the litigation.

We do not have an MDL right now. But the judge who has been assigned these cases in Boston is treating the 100 plus cases that have been filed as if there was a consolidated action.

December 10, 2024: Bigger Picture

The BioZorb lawsuits point to systemic issues in how medical devices like the BioZorb Marker are brought to market. Allegations that Hologic marketed the device for unapproved uses and failed to provide adequate warnings raise concerns about whether corners were cut in the rush to profit from a vulnerable patient population. The FDA’s subsequent recall and safety communications suggest these risks were foreseeable, yet not properly addressed.

December 9, 2024: Off-Market Uses in Focus

Plaintiffs’ Biozorb Marker lawsuits drill down on allegations of off-label promotion. This is a critical yet often overlooked aspect of medical device litigation but it will take center stage in this litigation. While the FDA approved BioZorb for radiographic marking, the device was allegedly marketed to fill tissue gaps and improve cosmetic outcomes—claims the FDA explicitly did not approve. This discrepancy raises the question of whether patients were unknowingly subjected to unapproved uses of a device that introduced unforeseen risks. These suits will dive into how off-label marketing practices can blur the lines of responsibility, leaving patients to suffer the consequences of decisions they were not fully informed about.

December 7, 2024: FDA Calls for Reporting on Adverse Events

The FDA reiterated the importance of patients and physicians reporting adverse events related to the BioZorb Marker. Through its MedWatch Online Voluntary Reporting System, the FDA seeks to collect data to assess the full scope of complications associated with the device. This step emphasizes the regulatory body’s heightened concern over the product’s safety profile and highlights the growing need for transparency in medical device monitoring. Experts believe this increased oversight could play a significant role in setting new standards for post-market surveillance of medical devices.

December 1, 2024:  Balancing Innovation with Safety

The BioZorb marker lawsuits reflects a broader challenge in healthcare: balancing innovation with patient safety. While advanced devices like BioZorb promise improved outcomes, they must undergo rigorous testing to ensure those benefits outweigh potential risks. When complications like migration and infection arise, it is often the patients—already in vulnerable states—who bear the burden. This lawsuit is a reminder that the pursuit of innovation should never come at the expense of transparency, safety, or the well-being of those the device is intended to help. The court’s handling of this case may serve as a benchmark for future litigation in the medical device field.

October 26, 2024: FDA Issues Safety Communication

The FDA released a Safety Communication advising healthcare providers and consumers to discontinue the use of BioZorb breast markers due to serious risks, including migration, pain, and infection. This announcement followed mounting reports of adverse events and underscored the regulatory agency’s recognition of the device’s failure to meet safety standards. With growing concerns about the long-term effects of such devices, the communication has prompted renewed discussions about how manufacturers disclose risks to providers and patients.

October 23, 2024: Hologic Announces Urgent Device Recall

Hologic, Inc. issued an urgent recall of all unused BioZorb Markers and BioZorb LP Markers. The Biozorb recall cited a range of adverse outcomes, including rashes, fluid buildup, device migration, and in some cases, the need for surgical removal. For patients and their healthcare providers, this recall marked a turning point, as it confirmed the severity of the risks that had previously been suspected but not officially acknowledged. Analysts suggest that this recall will likely lead to significant financial and reputational challenges for Hologic.

September 28, 2024: Court Allows Plaintiffs’ Claims to Proceed

U.S. District Judge Allison D. Burroughs denied Hologic’s motion for summary judgment, enabling the claims to move forward. This decision was pivotal, as it affirmed the plaintiffs’ right to pursue their allegations that the BioZorb Marker’s defective design caused significant harm. This ruling also put additional pressure on Hologic to either prepare for protracted litigation or consider settlement negotiations to avoid prolonged courtroom battles.

August 20, 2024 – “Sort of” BioZorb Class Action Lawsuit

The BioZorb lawsuits are not an MDL class action.  Still, they are 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, scheduled to begin in July 2025, 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 compensation amounts.

June 5, 2024: Experts Raise Concerns Over BioZorb Testing

Several industry experts voiced concerns that the BioZorb Marker may not have undergone adequate real-world testing before its release. These perspectives were shared during a healthcare conference where panelists emphasized the importance of simulating diverse patient scenarios during pre-market testing. This raised questions about how medical devices are approved and whether regulatory agencies should require more rigorous real-life testing protocols.

May 15, 2024:  510(k) Approval

The BioZorb recall puts a familiar spotlight on the 510(k) process. Unlike the more rigorous Premarket Approval (PMA) process,, you do not need clinical trials if the device is deemed “substantially equivalent” to existing products. is that a good idea for complex devices like BioZorb? (No.)

The reliance on 510(k) approval is central to many medical device lawsuits, as plaintiffs argue that the process allows manufacturers to sidestep critical testing. In BioZorb lawsuits, attorneys are scrutinizing whether Hologic took advantage of this expedited pathway, bypassing necessary safeguards to prioritize speed to market over patient safety.

For plaintiffs, the FDA’s shifting position serves as a double-edged sword: it bolsters claims of inadequate testing while also providing the defense with a potential argument that the device met regulatory standards at the time of approval.  You can be sure Hologic will try to take cover under the FDA’s umbrella of approval in every BioZorb lawsuit that is filed.

May 1, 2024: FDA Classifies BioZorb Recall as Class I

The FDA officially classified the BioZorb recall as a Class I recall. This is big deal, it is the most severe category, reserved for situations where use of a device could 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.

February 26, 2024: Hologic Issues Medical Device Safety Notification

Hologic issued an initial safety notice to patients and healthcare providers, acknowledging potential risks associated with the BioZorb Marker, including device migration and infection. This early notice set the stage for further investigations into the device’s safety and signaled the beginning of what would become a large-scale recall and legal battle.

The BioZorb Device

The BioZorb device, manufactured by Hologic, Inc., is an implantable marker designed to assist breast cancer patients following a lumpectomy. BioZorb is a three-dimensional, bioabsorbable structure composed of polylactic acid (PLA) with six titanium markers embedded in a spiral or circular design. These titanium clips serve as radiopaque “targets,” enabling radiologists to pinpoint the location for focused radiation therapy.

While BioZorb was cleared by the FDA for marking breast tissue sites post-surgery, Hologic has marketed the device beyond these bounds, promoting its benefits for filling tissue space and improving cosmetic outcomes—claims the FDA has not approved. This marketing has raised significant concerns, especially as BioZorb’s advertised benefits have led patients to expect better results in both radiation targeting and cosmetic recovery.

In fact, these off-label promotional claims are now at the heart of the BioZorb lawsuit. Patients like the plaintiff received this device believing it would resorb naturally and pose no long-term health risks. Unfortunately, that has not been the case for many women. Complaints of persistent pain, hardened masses, non-absorption, and the formation of scar tissue at the implantation site have become all too common. Worse yet, these complications can mimic the symptoms of new cancerous growths, leading to ongoing emotional trauma and distress.

FDA Public Safety Warning About BioZorb

The FDA has issued two critical notices concerning BioZorb’s risks. In February 2024, the FDA released a public safety notice regarding the BioZorb. The FDA notice warned patients and health care providers that there was a significant risk of serous health complications associated with the BioZorb.

The FDA noted that adverse event reports have indicated that the BioZorb can cause a number of complications, including infection, fluid buildup (seroma), device moving out of position (migration), device breaking through the skin (erosion), pain, discomfort from feeling the device in the breast, rash, other complications possibly associated with extended resorption time.

The FDA classified Hologic’s notification to healthcare providers as a Class I recall, which is a big deal.  This indicates a serious risk of injury or death.  The safety notice warned that many of these complications can be harmful and require additional treatment of surgery to remove the device from the patient’s body.

The safety notice further explained that the BioZorb has only received FDA clearance for use as a radiographic marker for sites in soft tissue. It has NOT been cleared or approved for use to fill space in tissue or improve cosmetic outcomes.

BioZorb Lawsuit

Manufacturers of medical devices or implants, such as BioZorb, have a legal obligation to ensure that their products are safe for their intended use. When a product is unsafe due to a defective design, a manufacturing flaw, or a negligent failure to warn about certain risks, the manufacturer can be held responsible for injuries caused by that product.

The BioZorb lawsuit is centered around an implantable device designed to serve as a three-dimensional marker for soft tissue sites after breast cancer surgeries like lumpectomies. With its spiral structure made from a bioabsorbable compound, the device includes six titanium radiopaque clips intended to guide radiation therapy. It works. But plaintiffs in these cases are alleging that instead of integrating seamlessly into their recovery process, BioZorb has caused painful scarring and infection. These complications were not adequately disclosed. That is the foundation of this litigation.

BioZorb’s design, compounded by misleading marketing, has left many patients unprepared for the realities of their post-implantation experience. Biozorb lawsuits against Hologic assert that the company failed to adequately warn patients and doctors about the potential for serious complications, such as chronic pain, tissue inflammation, disfigurement, and device migration.

Plaintiffs argue that Hologic’s instructions for use (IFU) lack critical warnings about BioZorb’s slow or incomplete absorption and omit necessary information about increased radiation dosing risks, which can lead to visible skin damage. In marketing BioZorb as a space filler and cosmetic enhancer, Hologic is also accused of promoting off-label uses without disclosing the risks, potentially leading doctors to recommend the device without a full understanding of its safety profile.

The manufacturer of the BioZorb, Hologic, may well be required to provide settlement compensation to victims for injuries caused by BioZorb due to complications associated with the implant. Anyone who had the BioZorb implanted and subsequently suffered complications that were caused by defects in the design of the BioZorb or shortcomings in the instructions for the BioZorb can file a product liability and get financial compensation.

A growing number of BioZorb lawsuits have already been filed across the country. Hundreds and possibly thousands more are expected to be filed moving forward as new patients suffer complications and injuries.

BioZorb Injuries and Complications

The BioZorb device, intended to aid in breast tissue marking and healing, has instead caused significant harm to many patients. One of the most critical issues involves the device failing to naturally resorb as promised, leading to additional invasive surgeries for removal. These surgeries often result in permanent disfigurement, scarring, and ongoing emotional distress.

Our firm is actively investigating claims and accepting cases from individuals who have experienced the following injuries or complications linked to BioZorb implants:

  • Infection: Severe and sometimes recurring infections at the implant site.
  • Fluid Buildup (Seroma): Accumulation of fluid around the implant, causing discomfort and requiring medical intervention.
  • Migration: Instances where the implant moves out of its intended position, leading to additional complications and corrective surgeries.
  • Erosion: The implant breaks through the skin, resulting in pain and visible disfigurement.
  • Delayed or Failed Reabsorption: The device not resorbing as intended, leaving a palpable lump, chronic pain, or requiring surgical removal.

BioZorb Marker Lawsuit & Titanium Breast Marker Lawsuit Timeline

2013-2015: Development & FDA Clearance

2013: BioZorb, a titanium-based breast marker, is developed by Focal Therapeutics, Inc. as a bioabsorbable device designed for breast cancer patients undergoing lumpectomy.
2014: The FDA grants 510(k) clearance for BioZorb, allowing its sale without requiring clinical trials, as it was deemed “substantially equivalent” to existing breast markers. Many lawsuits involve drugs and medical devices that got this backdoor 510(k) clearance.
2015: Focal Therapeutics begins marketing BioZorb, emphasizing its benefits for radiation targeting and claiming cosmetic improvements—despite no FDA approval for breast tissue reconstruction.

2016-2018: Adoption & Early Complaints

2016: BioZorb gains widespread use among breast surgeons, marketed as an innovative solution for marking lumpectomy sites.
2017: Reports emerge of severe complications, including device migration, chronic pain, infection, and non-absorption, leading to revision surgeries for removal.
2018: Patients file initial complaints alleging BioZorb is not bioabsorbing as expected, with some experiencing device protrusion years after surgery, fueling early **BioZorb marker lawsuit** discussions.

2019-2021: Hologic Acquisition & Increasing Concerns

2019: Hologic, Inc., a major medical device manufacturer, acquires Focal Therapeutics for $125 million, inheriting BioZorb, and its litigation risk, as part of its breast health portfolio.
2020: Lawsuits against BioZorb begin to surface quietly as patients report ongoing pain, scarring, and device failures.
2021: Titanium breast marker complaints increase as surgeons question whether the device’s rigid titanium clips contribute to prolonged complications, worsening patient outcomes.

2022-2023: Litigation Growth & FDA Scrutiny

2022: Patients suffering from severe complications seek legal representation, sparking a wave of BioZorb marker lawsuits* over undisclosed risks.
June 2023: The FDA initiates an investigation into BioZorb following a surge in adverse event reports from patients and surgeons.
December 2023: Hologic faces increasing legal scrutiny as more women come forward, reporting unnecessary procedures and emotional distress due to BioZorb-related complications.

2024: FDA Recall & Explosive Lawsuits

February 26, 2024: Hologic issues a safety warning admitting to potential risks, including device migration, infection, and pain.
May 1, 2024: The FDA issues a Class I recall, the most severe category, citing a risk of serious injury or death from BioZorb complications.
June 5, 2024: Medical experts publicly criticize the FDA’s approval process, arguing that BioZorb should have undergone clinical trials before market clearance instead of sneaking through the back door.
August 20, 2024: Titanium breast marker lawsuit claims are consolidated (but not as a class action lawsuit or MDL) in the U.S. District Court of Massachusetts under Judge Allison Burroughs.
September 28, 2024: Judge Burroughs denies Hologic’s motion to dismiss, allowing BioZorb marker lawsuits to proceed.
October 23, 2024: Hologic issues a nationwide recall of all remaining BioZorb units due to overwhelming safety concerns.
December 12, 2024: Over 100 lawsuits are filed against Hologic. Our lawyers suspect there will still be many more, but this is unlikely to be a huge mass tort.

2025: Litigation Moves Toward Trial

January 16, 2025: Judge Burroughs denies Hologic’s motion for summary judgment, allowing the first **BioZorb marker lawsuit** bellwether trial to proceed.
January 29, 2025: The FDA issues a warning letter to Hologic, citing **design flaws, inadequate safety testing, and failure to report adverse events**.
February 13, 2025: Plaintiffs push to introduce recall evidence in early cases, but the court denies the motion. This type of evidence is commonly not allowed at trial but plaintiffs thought they had exceptions to get around the general rule.
February 21, 2025: Judge Burroughs schedules the first BioZorb trial for September 8, 2025, with bellwether cases expected to influence settlement negotiations.

 

BioZorb Legal Allegations and Theories of Liability

In the BioZorb lawsuits, the plaintiffs are bringing claims under several legal theories, including failure to warn, design defect, and negligence. At the core of these allegations is the argument that Hologic knew—or should have known—about the potential risks associated with the BioZorb device, but failed to adequately warn physicians or patients.

  1. Failure to Warn: The instructions for use (IFU) provided with the BioZorb device lack critical information regarding the potential for non-absorption, hardened masses, and long-term complications. While the IFU suggests that the device may resorb within one year, plaintiffs have reported cases where the device failed to resorb at all, leading to painful and sometimes disfiguring outcomes. Moreover, the marketing of the device included claims about improved cosmetic results and post-surgical recovery benefits that were not substantiated by clinical data and were beyond the scope of the FDA’s clearance.
  2. Design Defect: The spiral or helical shape of the BioZorb device, along with the bioabsorbable polylactic acid compound, may be inherently flawed. The design elements, such as its shape and material, have been shown to contribute to complications like infection, migration, and increased radiation exposure, which are not only dangerous but can also necessitate additional surgeries. This presents a significant risk-benefit imbalance, one that plaintiffs argue should have been addressed by the manufacturer.
  3. General Negligence: Hologic’s failure to adequately test and monitor the performance of BioZorb, as well as its decision to promote the device for off-label uses, has resulted in harm to patients. The plaintiffs claim that had the company adhered to reasonable standards of care, many of these complications could have been avoided or mitigated.

BioZorb Lawsuit Settlement Amounts and Jury Verdict Predictions

Understanding the potential financial outcomes of the BioZorb lawsuits are crucial for plaintiffs weighing their legal options. While it is still early in the litigation process—way too early, actually—our lawyers take what we know from similar medical device lawsuits to make early predictions on settlement amounts and jury payouts in these lawsuits.

Settlement values in medical device cases generally vary depending on the severity of the injury, the level of negligence proven, and the potential for punitive damages. Based on the nature of the allegations in the BioZorb lawsuit, our lawyers think individual settlements could range from $150,000 to $500,000 per plaintiff if these lawsuits are as successful as we hope.  For cases involving severe injuries, such as extensive scarring, multiple surgeries, or significant emotional distress, settlement compensation may exceed $500,000. In multi-plaintiff settlements, such as those seen in multidistrict litigation (MDL) consolidations, total settlement funds could reach into the tens of millions of dollars.

Jury verdicts can be more unpredictable but also significantly higher than settlements in cases where plaintiffs can demonstrate a clear connection between the BioZorb device and their injuries. If a jury finds that Hologic acted with gross negligence or willful misconduct—particularly in light of the alleged off-label promotion—verdicts could reach over $1 million or more per plaintiff. If a jury finds there are punitive damages, really the sky is the limit.   In cases where the plaintiff has suffered permanent disfigurement, or the BioZorb device caused symptoms that mimic a new cancerous growth, jury verdicts would likely be in the millions.

Contact Us About a BioZorb Lawsuit

If you suffered complications related to a BioZorb implant device, contact our national product liability lawyers today at 800-553-8082 or contact us online.

 

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