in Re: Thermigen, LLC

Court of Appeals of Texas·Decided April 9, 2020·No. 05-20-00246-CV·Published

Opinion

Conditionally Granted and Opinion Filed April 9, 2020

S In The

Court of Appeals

Fifth District of Texas at Dallas No. 05-20-00246-CV

IN RE THERMIGEN, LLC, Relator

Original Proceeding from the 134th Judicial District Court Dallas County, Texas

Trial Court Cause No. DC-17-07119

MEMORANDUM OPINION

Before Chief Justice Burns and Justices Osborne, and Reichek Opinion by Justice Reichek The underlying proceeding involves burn injuries the Plaintiff allegedly

sustained when she underwent a skin-tightening procedure on her neck. In this original proceeding, Relator Thermigen, LLC (“Thermigen” or “Relator”) seeks a writ of mandamus challenging the trial court’s January 23, 2020 discovery order as overbroad. Specifically, Relator objects that the trial court ordered it to produce (1) complaints of adverse events relating to the transcutaneous procedure, which was not the kind of procedure Plaintiff underwent; (2) information for adverse events other than thermal burn injuries; and (3) information related to injuries that occurred after the Plaintiff’s injury.

After reviewing Relator’s petition, Real Party in Interest’s response, Relator’s reply, the mandamus record, and sealed supplemental mandamus record, we conclude that Relator is entitled to partial relief because the order is overbroad insofar as it directs discovery for “all adverse events, regardless of injury,” rather than limiting the discovery to adverse events relating to the generator’s alleged temperature malfunctions.

Background

Plaintiff underwent an elective skin-tightening procedure on her neck. That

procedure was performed with the ThermiRF system, a radiofrequency generator designed and manufactured by Relator. After allegedly suffering burns during the procedure, she sued Relator and asserted negligence and strict liability claims based on the allegedly defective design, manufacture, and marketing of the device.

The ThermiRF system uses temperature-controlled radiofrequency technology to heat targeted areas of skin. According to the declaration of ThermiGen Quality Director John Anderson, the ThermiRF system can be used on skin surfaces or beneath the skin. The generator is the same for each procedure, but the handpiece and application differ depending on the type of procedure.

Transcutaneous procedures, which do not break the skin, involve recommended temperature settings of 40°C to 45°C and use an electrode with a larger contact surface that is attached to a handpiece ergonomically designed for the intended procedure. Percutaneous procedures (the kind that Plaintiff underwent)

involve an incision and the insertion of the electrode beneath the skin. These procedures employ higher recommended temperature settings of 50°C to 70°C, and the electrode is a cannula insulated sufficiently to expose only a 5mm or 10mm contact surface at the tip. A thermal camera is also used in percutaneous procedures to measure the heat temperature. A single user manual exists for the ThermiRF system, with separate instructions for the different modes of operation.

On January 25, 2019, Plaintiff served her Fifth Request for Production, which contained twelve detailed requests. In summary, she sought:

 information regarding reports about the ThermiRF system causing burns;

 information regarding reports about the ThermiRF system having temperature related problems (such as unexpected temperature spikes or inaccurate temperature readings);

 underlying reports regarding injury incidents listed in previously produced documents;

 information reflecting ThermiGen’s decision to report or not report incidents of injury or malfunction of the ThermiRF system; and

 information pertaining to clinical trials for the ThermiRF system.

Relator objected on the grounds that the requests were overly broad, unduly burdensome, not reasonably limited in time, and not limited to “substantially similar” incidents. Plaintiff filed a motion to compel.

The trial court held a hearing on the motion to compel. At the hearing, Plaintiff argued that she was entitled to information about incidents, not just injuries,

because prior discovery had revealed numerous complaints about the ThermiRF system “shutting off too much” or having too many spikes in temperature. The trial court agreed and indicated that it was not inclined to limit its discovery order to “injury,” finding the term too subjective. The court also addressed the distinction between percutaneous and transcutaneous procedures at length. After noting that both procedures utilized the same generator and possibly the same software and that there were problems reported with both applications, the court indicated it would order discovery for both percutaneous and transcutaneous procedures. The court also indicated that it would order discovery of incidents “related to temperature.”

On January 23, 2020, the court issued a discovery order directing Relator to produce the following:

 “The complete investigation file for all adverse events, regardless of injury or bodily location, relating to the percutaneous procedures of the ThermiRF device”; and

 “[a]ll complaints of adverse events, regardless of injury or bodily location, relating to the transcutaneous procedures of the ThermiRF device.”

In this mandamus proceeding, Relator complains the trial court’s order is overbroad to the extent it compels production of complaints and documents that concern (1) incidents that did not result in injury, (2) injuries not involving thermal burns, (3) injuries that occurred after the date of Plaintiff’s injury, and (4) transcutaneous procedures. In response, Plaintiff argues that she is entitled to information about incidents, not just injuries, because earlier discovery had

uncovered multiple adverse events involving temperature spike incidents and dangerous heat levels with the generator, and such information was relevant to her theory that this type of defect caused her injury. Plaintiff further contends that, because the same ThermiRF generator turns radiofrequency energy into heat regardless of application, she should be able to obtain discovery relating to both transcutaneous and percutaneous procedures.

Standard of Review

Mandamus is warranted when the relator demonstrates a clear abuse of

discretion and there is no adequate appellate remedy. In re Prudential Ins. Co. of Am., 148 S.W.3d 124, 136–36 (Tex. 2004) (orig. proceeding); Walker v. Packer, 827 S.W.2d 833, 839 (Tex. 1992) (orig. proceeding). The Relator here has the burden of establishing both prerequisites to mandamus relief, and this burden is a heavy one. See In re CSX Corp., 124 S.W.3d 149, 151 (Tex. 2003) (orig. proceeding) (per curiam). A trial court abuses its discretion if it reaches a decision that is so arbitrary and unreasonable that it amounts to a clear and prejudicial error of law or if it clearly fails to correctly analyze or apply the law. In re Olshan Found. Repair Co., LLC, 328 S.W.3d 883, 887–88 (Tex. 2010) (orig. proceeding).

An order that compels overly broad discovery is an abuse of discretion for which mandamus is the proper remedy. In re Deere & Co., 299 S.W.3d 819, 820 (Tex. 2009) (orig. proceeding) (per curiam). Whether discovery is overbroad in

products liability cases depends on whether the order covers products relevant to the case and is reasonable in its scope. Id.

Discussion

The rules of civil procedure provide that the scope of discovery includes any unprivileged information that is relevant to the subject of the action, even if it would be inadmissible at trial, as long as the information sought appears “reasonably calculated to lead to the discovery of admissible evidence.” TEX. R. CIV. P. 192.3(a); see also In re CSX Corp., 124 S.W.3d at 152 (explaining that scope of discovery is generally within trial court’s discretion, but trial court must make effort to impose “reasonable discovery limits”). 1. “Adverse events, regardless of injury”

Free access — add to your briefcase to read the full text and ask questions with AI

in Re: Thermigen, LLC, (Tex. Ct. App. 2020).

in Re: Thermigen, LLC (in Re: Thermigen, LLC) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

Related

In Re CSX Corp.
124 S.W.3d 149 (Texas Supreme Court, 2003)
In Re Prudential Insurance Co. of America
148 S.W.3d 124 (Texas Supreme Court, 2004)
In Re Deere & Co.
299 S.W.3d 819 (Texas Supreme Court, 2009)
Columbia Medical Center Subsidiary, L.P. v. Meier
198 S.W.3d 408 (Court of Appeals of Texas, 2006)
In Re Exmark Manufacturing Co.
299 S.W.3d 519 (Court of Appeals of Texas, 2009)
Walker v. Packer
827 S.W.2d 833 (Texas Supreme Court, 1992)
in Re Navistar, Inc.
501 S.W.3d 136 (Court of Appeals of Texas, 2016)
in Re Sun Coast Resources, Inc.
562 S.W.3d 138 (Court of Appeals of Texas, 2018)
In re Heb Grocery Co.
375 S.W.3d 497 (Court of Appeals of Texas, 2012)
In re Nat'l Collegiate Athletic Ass'n
543 S.W.3d 487 (Court of Appeals of Texas, 2018)