ABSTRACT Objective

To identify and review the outcomes of bellwether cases related to inferior vena cava (IVC) filter multidistrict litigations (MDLs).

Methods

The legal research database, LexisNexis, was used to identify all cases related to IVC filters. Cases unrelated to the MDLs were excluded. Court documents recording the proceedings for bellwether cases sent to jury trials were retrieved from the LexisNexis subsidiary, Law360. Information on plaintiffs, filter models, reported complications, filed claims, decision-making body, verdicts, and rewards were reviewed.

Results

A total of 678 cases pertaining to IVC filters were found on the database, of which 12 were identified as bellwether cases for the MDLs. Of the 12, two (16.7%) were initially ruled in favor of the plaintiffs in jury trials, but the judgment for one of these was later vacated by a judge. The remaining ten (83.3%) were decided for the manufacturers by judges and juries.

Discussion

Verdicts in all bench trials were in favor of manufacturers, suggesting that judges perceive the presented complications by patients to be within the normal realm of expected risk of IVC filters. The findings of this study emphasize treating physicians’ legal responsibility to adequately warn patients of all the associated risks with IVC filters. The findings also indicate that physicians can still be found liable in product liability cases directed at manufacturers. Physicians should continue active monitoring of patients to optimize retrieval windows.

Article InfoPublication History

Accepted: May 3, 2022

Received in revised form: April 7, 2022

Received: December 23, 2021

Publication stageIn Press Journal Pre-ProofFootnotes

Statements and Declarations

a. Conflict of interest: none

b. Conflict of interest: none

c. Conflict of interest: Dr. Funaki is a committee member of SentryIDE | IVC Filter Study Data Monitoring, an advisory board member for Balt; and has been a speaker for Canon.

d. Conflict of interest: none

e. Conflict of interest: Dr. Ahmed reports grants from Canon Medical Systems Corporation, outside the submitted work; and has been a speaker for Argon Medical Devices Inc., Cook Medical Inc., Canon Medical Systems Corp., Philips Corp., Boston Scientific Corp., Johnson and Johnson, Cardiva Medical Inc. Dr. Ahmed is also a member of the advisory board for Boston Scientific Corp. and Genentech Inc.

Contributor Statements:

Mr. Ahmad participated in study concept and design, interpretation of results, drafting the manuscript, and orchestrated critical revision of the manuscript by all co-authors.

Dr. Wadhwa participated in interpretation of results and writing and critical revision of the manuscript.

Dr. Funaki participated in interpretation of results and writing and critical revision of the manuscript.

Mrs. Jilani participated in study concept and design, data analysis and interpretation, and writing of manuscript.

Dr. Ahmed participated in study concept and design, data analysis and interpretation, and the writing and critical revision of the manuscript.

Identification

DOI: https://doi.org/10.1016/j.jvsv.2022.05.005

Copyright

© 2022 Published by Elsevier Inc. on behalf of the Society for Vascular Surgery.

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