## Facts

- A minor with Type I diabetes used a Medtronic MMT-522 insulin pump with a Paradigm Infusion Set Model MMT-396 to deliver insulin subcutaneously.
- After an alleged hypoglycemic event on September 9, 2007, the minor suffered permanent brain damage; plaintiffs alleged over-delivery of insulin caused by device malfunction.
- Plaintiffs sued Medtronic and infusion-set manufacturers (Unomedical entities) under theories including negligence, strict liability, breach of express warranty, and failure to warn, and sought punitive damages.
- In discovery, plaintiffs requested wide-ranging information spanning many years, including materials on other pump/infusion-set models, extensive adverse event information, global regulatory communications, and sales/market share/profit data.
- Defendants objected that the requests were overbroad, burdensome, and not proportional, particularly for adverse-event and worldwide regulatory materials, and argued other models were materially different from the specific devices at issue.

## Issues

1. Whether requested discovery about predicate and successor insulin-delivery devices beyond the specific pump and infusion set at issue was relevant and proportional under Federal Rule of Civil Procedure 26.
2. Whether plaintiffs could compel wholesale production of adverse-event reports across multiple product lines and long time periods, or whether discovery should be limited to systems and procedures for adverse-event handling.
3. Whether broad financial discovery (sales, market share, profits) was proportional at the discovery stage, particularly in relation to punitive damages.
4. Whether, and to what extent, plaintiffs could obtain domestic and foreign regulatory communications relating to the devices and alleged defects.

## Decision

- The court granted in part and denied in part plaintiffs’ motion to compel and Unomedical’s motion for a protective order.
- The court permitted limited discovery regarding other devices only where plaintiffs could pursue information about devices sharing common design and function with the specific pump and infusion set at issue.
- The court restricted adverse-event discovery, allowing inquiry into defendants’ procedures and systems for receiving, recording, and reporting adverse events, but denying demands for sweeping production of all adverse-event reports over a 15-year period.
- The court denied broad discovery into sales, market share, and profits at that time as not sufficiently proportional or tied to the claims, particularly given the undeveloped basis for punitive damages.
- The court allowed some discovery concerning regulatory communications, including foreign regulators, but limited it to matters and timeframes closely connected to the devices and alleged issues in the case.

## Legal Principles

- Under Federal Rule of Civil Procedure 26(b)(1), discovery must be both relevant to claims or defenses and proportional to the needs of the case, considering burden and expense.
- In product-defect litigation, discovery into predicate and successor devices may be allowed only when the devices are sufficiently similar in design and function to permit meaningful comparison.
- Courts may limit production of adverse-event materials where the underlying data is available from public regulatory sources, while still permitting discovery into a manufacturer’s internal adverse-event handling practices.
- Broad financial discovery is commonly deferred or narrowed unless a legally and factually supported basis for punitive damages or other need is shown.
- Regulatory communications can be discoverable when tied to the device and alleged defect or warnings, but requests for undifferentiated global files may be curtailed as disproportionate.

## Conclusion

The court applied Rule 26 proportionality to narrow discovery in a medical-device products case, allowing targeted discovery into similar devices, adverse-event handling systems, and selected regulatory communications while rejecting sweeping adverse-event production and premature, broad financial discovery.


Kubicki ex rel. Kubicki v. Medtronic, Inc., 307 F.R.D. 291 (D.D.C. 2014)