Edwards v. Thermigen LLC

Background

Fernando Anthony Edwards sued Thermigen, LLC and SpineSmith Holdings, LLC, doing business as Celling Biosciences. Edwards alleged that Thermigen marketed and sold the ThermiVa medical device as approved by the Food and Drug Administration for several purposes, including minimizing vaginal laxity, eliminating vaginal atrophy, and improving vaginal vascularity. He alleged that the device did not work as advertised and that Thermigen’s representations induced him to pay $100,579.92 for a useless device. He also alleged that the representations exposed the physician at the medical office he administered to a risk of professional malpractice.

The complaint asserted claims under California law for unlawful, unfair, and fraudulent business practices; false advertising; deceit; and negligent infliction of emotional distress.

Thermigen’s Motion

Thermigen moved under Federal Rule of Civil Procedure 12(b)(4), 12(b)(5), and 12(b)(6). Rules 12(b)(4) and 12(b)(5) concern defects in the summons and service of the summons and complaint. Rule 12(b)(6) concerns whether the complaint states a legally sufficient claim.

Thermigen argued that it had not been properly served because the summons named only Celling Biosciences, Inc. rather than Thermigen. It also argued that service occurred more than 100 days after the complaint was filed. The court noted that no summons had been issued in Thermigen’s name, but found that Thermigen had not shown actual prejudice from the defect. The court also explained that Thermigen was not required to waive service, although refusing to waive service without good cause could result in responsibility for later service costs.

Thermigen separately argued that Edwards lacked the right to bring the claims because he did not purchase the device. The court treated this argument as an objection under Rule 17, which generally requires a case to be prosecuted by the real party in interest—the person or entity legally entitled to assert the claim. The purchase agreement identified Sharon de Edwards, MD OB/GYN as the company and Sharon de Edwards, MD as the physician, while listing Edwards as the contact. The agreement was signed by Edwards. The court found that the record did not establish whether Edwards purchased the device personally or purchased it as administrator of the medical office, and Thermigen presented no evidence identifying who paid for it.

Ruling

The court denied Thermigen’s motion to dismiss for insufficient service and insufficient process. It also denied Thermigen’s motion to dismiss for failure to state a claim. The court declined to treat the complaint as served merely because Thermigen refused to waive service and required Edwards to complete service on Thermigen within 30 days of the order.

The court denied the motion to dismiss without prejudice to Thermigen’s renewing its Rule 17 objection that the action was not prosecuted in the name of the real party in interest. The order did not resolve the factual and legal questions about whether Edwards or the medical office was the proper party. The ruling was issued by Judge Jacquelyn Corley.