Edwards v. Thermigen LLC

Background

Sharon de Edwards sued Thermigen LLC for allegedly fraudulently marketing and selling a medical device as approved by the U.S. Food and Drug Administration (FDA) to treat menopausal symptoms. Edwards moved for summary judgment on all of her claims. Summary judgment is a decision without a trial that may be entered when there is no genuine dispute over a material fact and the moving party is entitled to judgment as a matter of law.

The court denied Edwards’s motion. The claims depended on Edwards’s assertion that Thermigen salesperson Mike Shepard orally represented that FDA approval of the device to treat menopause was forthcoming. Shepard submitted a statement that he never made those representations. The court held that this conflicting evidence created a genuine dispute of material fact. The court said Edwards’s arguments addressed the weight of the evidence rather than eliminating the factual dispute required for summary judgment.

Real-Party-in-Interest Defense

Thermigen argued that Edwards’s medical practice corporation, identified in the opinion as “Sharon De Edwards, M.D., FACOG, NCMP, Incorporated,” purchased the device, making the corporation rather than Edwards the real party in interest. A real party in interest is the person or entity legally entitled to bring the claim.

The court found that the purchase agreement identified “Sharon de Edwards, MD OB/GYN” as the purchaser and did not identify the corporation. Applying California’s parol-evidence rule, which generally prevents use of outside evidence to change the terms of an integrated written agreement, the court concluded that the agreement was not reasonably open to Thermigen’s interpretation that the corporation purchased the device. The court stated that there appeared to be no genuine dispute that Edwards purchased the device and that Thermigen’s defense did not defeat summary judgment.

Edwards had not moved for summary judgment on this affirmative defense. The court nevertheless stated that it could grant summary judgment on the defense and ordered Thermigen to show cause, in writing, if it had a good-faith argument supported by admissible evidence that the corporation purchased the device. The court stated that, if Thermigen failed to do so, it would grant summary judgment for Edwards on the defense and remove that issue from the case.

Disposition

The court denied Edwards’s motion for summary judgment, and the order disposed of Docket No. 95. The opinion contains two different sets of deadlines for the show-cause process: one section states that Thermigen’s response was due June 27, 2024, with Edwards’s response due July 5, 2024; the conclusion states July 3 and July 10, 2024, respectively.