Warren v. ResMed Corp.

Background

Brooke Warren, the widower of Philip T. Warren and executor of his estate, brought a products-liability lawsuit against ResMed Corp., Apria Healthcare LLC, and Apria Healthcare Group Inc. The complaint alleged that Philip Warren died after being found unresponsive while using an Astral 150 ventilator. ResMed manufactured the ventilator, and Apria was described as a home-healthcare provider and retailer.

The amended complaint asserted New York-law claims involving negligence, design defect, manufacturing defect, failure to warn, breach of implied warranty, breach of express warranty, wrongful death, and loss of consortium. The defendants moved under Federal Rule of Civil Procedure 12(b)(6), which tests whether a complaint alleges enough facts to state a legally valid claim, to dismiss the failure-to-warn and express-warranty claims.

Failure-to-Warn Claims

The complaint alleged, upon information and belief, that Dr. David Berlin received ResMed’s Astral Series User Guide and Apria’s Patient/Caregiver Instruction before prescribing the ventilator. It also alleged that the warnings in those documents were inadequate.

The court held that the complaint did not plausibly allege that Dr. Berlin received the relevant warnings. Although the complaint described the contents of the allegedly inadequate warnings, it identified no facts supporting the belief that the defendants provided the documents to Dr. Berlin. The court therefore concluded that the failure-to-warn claims were based on a conclusory allegation and did not satisfy the pleading standard. The court treated the failure-to-warn theory as including both strict-liability and negligence theories because the complaint could be read to assert both, and it noted that New York treats those theories as identical for this purpose.

Express-Warranty Claims

The complaint alleged that the defendants’ written materials warranted that the ventilator was fit, reasonably safe, capable, and of merchantable quality. It also alleged that the materials promised continuous power if main power was disrupted and immediate audible and visual alerts in the event of a malfunction. The complaint asserted, upon information and belief, that Philip Warren and Dr. Berlin received, read, and reviewed the materials and that Dr. Berlin relied on the warranties when prescribing the ventilator.

The court held that the complaint did not allege sufficient facts showing that Dr. Berlin received and relied on the alleged warranties. The court rejected the argument that it was simply reasonable to assume that a prescribing doctor received and relied on documents accompanying a medical device. It also rejected reliance on a progress note submitted with Warren’s opposition papers. The note was written by a nurse practitioner, did not refer to the defendants’ materials, and did not support the allegation that Dr. Berlin relied on those materials. The court further stated that a plaintiff may not use discovery or outside documents submitted with opposition papers to repair an inadequate complaint.

Leave to Amend and Disposition

Warren requested permission to amend the complaint to add facts supporting the challenged claims. The court stated that amendment is generally allowed unless it would be improper, but noted that Warren had not identified what new information would be added. The court nevertheless allowed Warren to file a motion for leave to amend within 30 days. That motion had to include a proposed second amended complaint and a memorandum explaining why it would survive another dismissal motion.

The court granted the defendants’ motion to partially dismiss. The failure-to-warn and breach-of-express-warranty claims contained in Counts One, Two, Three, Six, and Seven were dismissed without prejudice. The opinion did not state that the other claims were dismissed by this order.