What Is New With Medical Device Lawsuits Mass Tort Litigation in September 2026? Latest court filings and agency notices and Key Takeaways

By Steve Levine · Updated September 25, 2026

September 2026 brought a $40 million Bard port-catheter verdict, new movement in major device MDLs, and a limitations ruling that shows how delay can defeat a claim. FDA notices also addressed serious problems involving an esophageal monitoring capsule, a heart-pump controller, and nitric-oxide delivery systems. A mass tort combines similar personal-injury lawsuits for coordinated pretrial proceedings while preserving each plaintiff's individual claim. The month's developments may influence case strategy and patient safety, but one verdict or recall does not automatically establish liability or compensation.

Bard port verdict tests the claims in MDL 3081
Paragard litigation approaches another test trial
New filing enters the Zimmer hip-prosthesis review process
Ninth Circuit ruling highlights filing deadlines
FDA notices require different responses

Bard port verdict tests the claims in MDL 3081

An Arizona federal jury awarded Kimberly Divelbliss $40 million after her implanted Bard port catheter fractured and migrated into her heart. The jury found defective design and inadequate warnings, and the injury allegations included two heart attacks, according to Langdon & Emison's September 11 report. The verdict was mixed. Jurors rejected the manufacturing-defect, concealment, and punitive-damages claims. Those findings matter because they separate alleged problems with the device's overall design and warnings from claims that this particular unit was improperly manufactured.

This was only the second bellwether trial in Bard port-catheter MDL 3081. Bellwethers are selected test cases intended to show the parties how juries may evaluate recurring evidence and legal theories. They do not decide the remaining lawsuits. The Judicial Panel on Multidistrict Litigation's September report counted 3,734 pending actions. No global settlement was documented, so other claimants do not receive payment from the Divelbliss verdict and must still establish their own injuries, timing, and legal claims.

Paragard litigation approaches another test trial

Paragard MDL 2974 had 4,185 pending actions on September 1. Plaintiffs allege that arms of the intrauterine device fractured during removal, sometimes leading to further medical treatment. The first test trial ended in a defense verdict. The next bellwether, *Robere v. Teva*, was scheduled for September 28, according to Settlement Record's September case update.

A defense verdict in one test case does not resolve thousands of other actions. Differences in removal records, device condition, injuries, warnings, and state law can produce different outcomes. The next trial may provide another data point, but it will not create an automatic settlement formula. Paragard has not been recalled. Patients should distinguish a pending products-liability MDL from an FDA recall: litigation allegations can proceed even when a device remains on the market.

New filing enters the Zimmer hip-prosthesis review process

On September 10, the Southern District of New York accepted *Faircloth v. Zimmer* as related to hip-prosthesis MDL 2859. The self-represented plaintiff alleged injuries involving an M/L Taper with Kinectiv stem and neck.

The court ordered Zimmer to address whether the action belongs in the MDL. That is a case-management step, not a ruling that the product was defective or caused the alleged injuries. Placement in an MDL can centralize discovery, motions, and other pretrial work with similar lawsuits. It does not turn the litigation into a class action, and each claimant generally retains an individual case.

Ninth Circuit ruling highlights filing deadlines

The Ninth Circuit affirmed dismissal of Ana Esperias's Bard inferior vena cava filter claims as untimely. The court concluded that she knew by 2020 that her filter was malpositioned and perforating nearby organs. Learning from a 2022 litigation advertisement that other people were suing did not restart California's two-year limitations period, according to the Ninth Circuit's September 4 decision.

The decision illustrates why the date a patient learns of an injury or device problem can matter more than the date the patient learns about litigation. Anyone evaluating a possible device claim should preserve records showing: Applicable deadlines depend on the claim and governing law. Waiting for an MDL settlement, another verdict, or a lawsuit advertisement can place an otherwise viable claim at risk.

The implantation, treatment, or removal dates.
When symptoms first appeared.
When imaging or a clinician identified the device problem.
When the patient first connected the injury to the device.
Any replacement, revision, or follow-up procedures.

FDA notices require different responses

FDA classified Medtronic/Given Imaging's removal of certain Bravo CF capsule-delivery devices as its most serious recall type. The agency reported 184 serious injuries associated with attachment or detachment failures. Facilities should quarantine affected lots expiring through October 20, 2027, and return them for replacement. On September 24, FDA gave the same serious classification to Abiomed's worldwide removal of Automated Impella Controllers. Purge-cassette recognition failures can delay or interrupt circulatory support.

Hospitals may continue using the controllers during phased servicing, but they should keep backups ready and follow alarm procedures. FDA's updated September 18 notice for affected NOxBOXi nitric-oxide systems called for revised instructions rather than device removal. Oxygen-tubing leaks can interrupt therapy or increase the nitric-oxide dose, with heightened risk for neonates who have congenital heart disease. No serious injuries or deaths had been reported as of August 12. The required response therefore depends on the notice: Patients should not stop treatment or alter an implanted or life-supporting device on their own. Facilities should identify affected models or lots from inventory records and follow the manufacturer and FDA instructions in the agency's Bravo CF recall notice.

Bravo CF: quarantine affected inventory and return it for replacement.
Impella controller: continue use during phased service only with the specified precautions, backup equipment, and alarm procedures.
NOxBOXi: follow the corrected instructions; the notice did not direct removal of the systems.

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