BioZorb Lawsuit

Summary and Breakdown of BioZorb Medical Device Lawsuit

More than 80 patients across the country have filed lawsuits against Hologic. All the BioZorb lawsuits are filed for the following reasons:

• The device didn’t dissolve as quickly as expected
• Some experienced ongoing pain
• Others developed complications requiring additional procedures
• Many were left with visible or palpable lumps where the device was implanted

The truth is that Hologic failed to properly warn people about the dangers of the BioZorb markers. As a result, may women are dealing with serious complications and painful side effects.

Case Background and Overview

The memorandum and order from the United States District Court of Massachusetts addresses summary judgment motions in a multi-plaintiff lawsuit against Hologic, Inc. regarding their BioZorb medical device. The case involves over 80 plaintiffs across 18 cases, with this particular order focusing on four plaintiffs: Rita Melkonian, Tricia Willard, Nerissa Burke, and Karen Ensley. Each woman underwent a partial mastectomy (also referred to as a lumpectomy or breast conservation surgery) in order to remove cancerous lesions. During those procedures, the women were implanted with a device called a BioZorb marker. This device is used to identify breast tissue surrounding the cancer tissue that was removed, so that it can be calibrated for radiation targeting.

The BioZorb Device

BioZorb is an FDA-approved Class II medical device used in breast cancer surgery. It consists of:

• A spiral-shaped bioabsorbable spacer
• Six titanium clips
• Designed to mark sites where cancerous lesions have been surgically removed
• Meant to facilitate targeted radiation treatment
• Expected to dissolve (resorb) over time

Legal Claims

The plaintiffs each filed four causes of action against Hologic:

1. Negligent Failure to Warn (Count I)
2. Negligent Design Defect (Count II)
3. Breach of Implied Warranty of Merchantability (Count III)
4. Negligence (Count IV)

Key Legal Issues

1. Choice of Law

The court had to determine which state’s laws would apply to each plaintiff’s claims. Despite Hologic being based in Massachusetts, the court ruled that:

• Each case would be governed by the law of the state where the plaintiff’s injury occurred
• Melkonian: California law
• Willard: Indiana law
• Ensley: North Carolina law
• Burke: Florida law

2. Learned Intermediary Doctrine

The central legal issue was the application of the learned intermediary doctrine, which states that:

• Medical device manufacturers have a duty to warn physicians, not patients
• Manufacturers can discharge their duty by providing adequate warnings to physicians
• Different states handle the doctrine’s application differently, particularly regarding the “heeding presumption”

Outcomes for Individual Plaintiffs

Rita Melkonian (California)

• Summary judgment DENIED
• Key factors:
  • California does not recognize heeding presumption
  • Evidence showed Dr. Bailey might have communicated different warnings to patient
  • Genuine dispute of material fact existed regarding causation

Tricia Willard (Indiana)

• Summary judgment DENIED
• Key factors:
  • Indiana recognizes heeding presumption
  • Dr. Hardley’s testimony was equivocal about whether stronger warnings would have changed her decision
  • Genuine dispute of material fact existed

Karen Ensley (North Carolina)

• Summary judgment DENIED
• Key factors:
  • Dr. McAlister’s testimony created genuine dispute of material fact
  • Her subsequent decision to stop using BioZorb undermined her testimony about warnings

Nerissa Burke (Florida)

• Summary judgment GRANTED
• Key factors:
  • Florida does not recognize heeding presumption
  • Burke failed to produce evidence that Dr. Williams would have changed his decision with adequate warnings
  • No genuine dispute of material fact regarding causation

Significance and Implications

Legal Precedent

The case demonstrates:

• The complexity of multi-state product liability litigation
• The importance of state-specific applications of the learned intermediary doctrine
• The critical role of physician testimony in medical device cases

Procedural Impact

The ruling:

• Allows three of four cases to proceed to trial
• Establishes framework for handling similar claims in the broader litigation
• Highlights the importance of gathering specific physician testimony about warning adequacy

Takeaways from the BioZorb Lawsuit

This case illustrates the complexities of medical device litigation, particularly when:

• Multiple state laws are involved
• The learned intermediary doctrine applies
• Causation must be proven through physician testimony
• Different states have varying standards for proving causation in failure-to-warn cases

The court’s detailed analysis provides a roadmap for similar cases and emphasizes the importance of developing specific evidence about how stronger warnings might have altered physician behavior in medical device cases.

Filing a BioZorb Lawsuit

If you are considering filing a BioZorb lawsuit, call our office today. Our BioZorb lawsuit lawyers can help you and your family. We have recovered hundreds of millions of dollars for injury victims all across the U.S. Our consultations are free and if we take your case, you won’t pay us anything unless we win your case.

The full PDF document for the BioZorb lawsuit can be found here.