This article sets out a litigation support standard for managing drug and device product liability inventories. Defense counsel and litigation operations teams need repeatable execution, defensible medical fact development, and operational visibility across an MDL or other coordinated docket. The objective is simple: convert high-volume medical records into a consistent work product that supports strategy, expert work, depositions, motions, and settlement evaluation without reinventing the process in every file.
The purpose of this standard is to create a consistent operating model for record retrieval and completeness control, chronology and issue development, imaging acquisition, bellwether readiness deliverables, and inventory-level reporting. It applies to drug and device product liability matters in MDLs and similar mass tort structures, used by internal litigation operations, outside counsel teams, and outsourced litigation support vendors.
Guiding principles
The standard rests on core, non-negotiable pillars. Comparability matters more than individual writing style; every plaintiff file should produce outputs that can compare across the inventory. The work product is anchored to the record with Bates/page references or clear source identifiers. Chronologies are tools for decision-making. Imaging evidence has its own workflow. Finally, visibility is a form of risk control; leadership must be able to see what is complete, what is missing, and what is next. Databases built for this type of work are key to successful litigation.
Intake and case setup
At intake, each case should be set up with the minimum required inputs that allow the pipeline to operate. That includes plaintiff identifiers, counsel-of-record information, claimed injury, and alleged exposure/implant dates if known, product identifiers, a starting provider list, and any prior productions with Bates ranges.
Record retrieval and completeness controls.
Record retrieval is not a clerical pre-step; it is part of case evaluation. At minimum, retrieval efforts should cover primary care, relevant specialists, hospital and ED encounters, operative reports, and implant logs for device cases, pharmacy, and medication administration records for drug cases when relevant, imaging reports and films, labs and pathology, and functional status documentation. Missing critical components must be flagged explicitly, such as missing operative reports, missing imaging films, missing pathology, and missing medication histories. Each plaintiff’s file should have a record status sheet that shows what was requested, what was received, what is missing, and what is queued for re-request with priorities.
Chronology development standard
Chronology is the backbone work product because it becomes the reference point for experts and counsel. Every chronology should follow the same headings to ensure comparability. At minimum, it should cover baseline medical history and risk factors, product exposure or implant context, symptom onset and progression, diagnostics with dates, treatment and interventions including revisions/removals, outcomes and status, relevant medications, prior similar complaints, and open questions or missing records that affect evaluation. The required outputs are a cited chronology and a dated event index so a user can navigate quickly without rereading the entire document.
Imaging workflow standard
Imaging has its own workflow because it often determines whether a claimed injury is supported, incidental, pre-existing, progressive, or temporally inconsistent with the alleged exposure/implant. The standard should require acquisition of films for imaging tied to alleged onset, baseline differential diagnosis windows, and decision points such as surgery, revision, or removal. Reports and films are managed separately because “we have the report” is not the same as “we have the images.” Each plaintiff file should include an imaging index listing study type, body region, date/time, facility, key impression language as needed, and linkage to chronology events. A “key imaging” list should be created for expert review, so attention is directed to the studies most likely to matter. The practical rule is to start imaging acquisition early; imaging lag is a predictable bottleneck in MDL operations.
RnG Medical Legal Solutions
If you want to implement a litigation support standard like this with nurse-led medical record review, managed record retrieval, and imaging workflow support for high-volume product liability matters, R&G Medical Legal Solutions provides litigation support services designed to help defense teams work with clarity and consistency. Learn more at rngmedical.com.