Edwards v. Thermigen LLC
- Jacquelyn Corley
- 3:21-cv-01828
- U.S. District Court · Northern District of California
- 4
In Edwards v. Thermigen, Judge Corley denied Edwards’s summary-judgment motion because a factual dispute remained over Thermigen’s alleged FDA-approval representation.
Sharon de Edwards and Thermigen LLC, with the order also addressing Thermigen’s defense concerning whether Edwards or her medical-practice corporation purchased the device.
What happened
Sharon de Edwards sued Thermigen LLC, claiming it fraudulently marketed and sold a medical device as approved by the Food and Drug Administration to treat menopausal symptoms. Edwards asked the court to grant summary judgment on all her claims.
Thermigen argued that Edwards was not the proper plaintiff because her medical-practice corporation, rather than Edwards personally, bought the device. The court rejected that argument as a basis for defeating Edwards’s motion, relying on the purchase agreement’s identification of Edwards as the purchaser, but gave Thermigen an opportunity to show that a genuine factual dispute exists on that issue.
Judge Jacquelyn Scott Corley denied Edwards’s summary-judgment motion because Thermigen’s salesperson denied making the alleged representation, creating a genuine dispute about a fact central to Edwards’s claims. The order did not grant summary judgment on the real-party-in-interest defense; it said the court would do so if Thermigen failed to show cause.
The detailed version
- Edwards v. Thermigen LLC · No. 3:21-cv-01828
- Jacquelyn Corley
- June 27, 2024
Background
Sharon de Edwards sued Thermigen LLC, alleging that Thermigen fraudulently marketed and sold a medical device as approved by the U.S. Food and Drug Administration 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 the evidence shows no genuine dispute about a fact important to the outcome and the moving party is entitled to judgment as a matter of law.
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 proper plaintiff. The court rejected that defense as a reason to defeat Edwards’s motion. The purchase agreement identifies the purchaser as “Sharon de Edwards, MD OB/GYN” and does not identify the corporation as the purchaser. The court also concluded that the agreement’s terms were not reasonably open to Thermigen’s proposed interpretation and that the agreement barred reliance on outside evidence to contradict those terms.
The court stated that there appeared to be no genuine dispute that Edwards purchased the device. Because Edwards had not separately moved for summary judgment on Thermigen’s affirmative defense, however, the court did not then enter judgment on that defense. It ordered Thermigen to show cause in writing by June 27, 2024, if it had a good-faith argument, based on admissible evidence, that a genuine dispute existed about who purchased the device. Edwards could respond by July 5, 2024. The court stated that it would grant summary judgment for Edwards on that defense if Thermigen failed to show cause.
Disputed Representation
Edwards’s claims were based on her assertion that Thermigen salesperson Mike Shepard orally represented that Food and Drug Administration approval of the device to treat menopause was forthcoming. Shepard attested that he never made those representations. The court held that this conflict created genuine issues of material fact. The court said Edwards’s arguments went to the weight of the evidence and did not satisfy the summary-judgment standard.
Ruling
Judge Jacquelyn Scott Corley denied Edwards’s motion for summary judgment. The order disposed of Docket No. 95. It did not state that the case was dismissed or that judgment was entered on Edwards’s claims. It separately stated that summary judgment on Thermigen’s real-party-in-interest affirmative defense would be granted if Thermigen failed to show cause as ordered.
Read the full 4-page opinion on CourtListener, the free public archive maintained by the Free Law Project.