in Re: Thermigen, LLC

• Court: Court of Appeals of Texas
• Decided: April 9, 2020
• Docket: 05-20-00246-CV
• Status: 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)

–2– 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,

–3– 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 –4– 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

–5– 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”

Discovery should be limited to incidents involving circumstances relevant to

the underlying lawsuit. See In re Sun Coast Res., Inc., 562 S.W.3d 138, 150 (Tex.

App.—Houston [14th Dist.] 2018, orig. proceeding). Evidence of similar events is

probative if an adequate predicate is established. See In re HEB Grocery Co., 375

S.W.3d 497, 503 (Tex. App.—Houston [14th Dist.] 2012, orig. proceeding). An

unrelated incident may be relevant and admissible if it and the incident involved in

the lawsuit occurred under reasonably similar conditions, the two incidents are

connected in some special way, or the incidents occurred by means of the same

instrumentality. Columbia Med. Ctr. Subsidiary, L.P. v. Meier, 198 S.W.3d 408,

–6– 411–12 (Tex. App.—Dallas 2006, pet. denied). “Reasonably similar” generally

means the same type of occurrence. Id.; In re Sun Coast, 562 S.W.3d at 148.

In Sun Coast, the plaintiffs alleged Sun Coast was negligent in spilling or

overfilling an above-ground storage tank of gasoline, resulting in hazardous vapors

that ignited a fatal fire. 562 S.W.3d at 144. The plaintiffs sought, and the trial court

compelled, Sun Coast’s production of a “spill log” of all hazardous materials spills

for the previous five and a half years. Id. at 147. The plaintiffs argued the requested

information regarding prior hazardous materials spills was reasonably calculated to

lead to the discovery of evidence pertaining to Sun Coast’s knowledge of the

existence of prior spills and whether such spills were caused by conduct similar to

that alleged in the lawsuit. Id.

Sun Coast argued the trial court’s order, as worded, was overbroad because it

lacked any restrictions regarding subject matter or geographic scope and would

require Sun Coast to produce information about other incidents that bore no relation

to plaintiffs’ claims. The appellate court agreed, concluding the trial court’s order

compelled production of some relevant information but cast “too wide a net” by

failing to limit discovery to “incidents involving circumstances necessarily relevant

to the underlying lawsuit.” Id. at 148, 150. Specifically, the court observed the order

would include hazardous materials spills that may have resulted from an automobile

accident with one of Sun Coast’s tankers on the highway, which bore no relation to

the plaintiffs’ theory of negligence. Id. at 150. –7– Here, Plaintiff’s claims involve burn injuries she allegedly sustained during

the procedure performed with the ThermiRF system and its temperature-controlled

radiofrequency technology. But the trial court ordered Relator to produce (1) the

complete investigation file for all adverse events, regardless of injury or bodily

location, relating to the percutaneous procedures of the ThermiRF device and (2) all

complaints of adverse events, regardless of injury or bodily location, relating to the

transcutaneous procedures of the ThermiRF device. To the extent the order broadly

directs discovery for “all adverse events,” it necessarily captures incidents unrelated

to temperature-related problems, such as temperature spikes or excessive heating,

and therefore required Relator to produce evidence of incidents that were not

relevant to the underlying suit. As such, the order is overbroad.

Relator also complains that the order should be limited to incidents involving

only “injury,” not merely “adverse events.” Here, we cannot agree. Plaintiff alleges

that Relator knew, or in the exercise of ordinary care should have known, that

ThermiRF was defective and unreasonably dangerous to persons likely to use the

product. Therefore, past instances relating to temperature-related problems are

relevant to the issue of notice. See Alza Corp. v. Thompson, No. 13-07-00090-CV,

2010 WL 1254610, at *7 (Tex. App.—Corpus Christi–Edinburg Apr. 1, 2010, no

pet.) (mem. op.). While it is possible that not all responsive discovery will meet the

standards for admissibility at trial, this is not the standard for relevance at the

–8– discovery stage. See In re Exmark Mfg. Co., 299 S.W.3d 519, 528 (Tex. App.—

Corpus Christi–Edinburg 2009, orig. proceeding).

2. Transcutaneous procedures involving the ThermiRF device

Relator also complains that it is required to produce information regarding

transcutaneous procedures that involve the ThermiRF device. However, courts have

routinely permitted discovery involving other products if there is a connection

between the alleged defect and the discovery sought.

For example, In re Deere & Co. involved a plaintiff who was injured after a

backhoe loader step broke off under his weight and asserted, among others, a

products liability claim. 299 S.W.3d at 820. The trial court ordered discovery

regarding more than thirty product lines that included backhoes, tractors, and other

loaders. Id. Deere objected that the order was overly broad, but the supreme court

concluded that the discovery of other products was not an abuse of discretion

because the order was limited to products with handles and step assemblies similar

to the model at issue. Id. at 821.

Similarly, In re Navistar, Inc., 501 S.W.3d 136 (Tex. App.—Corpus Christi–

Edinburg 2016, orig. proceeding), involved the buyer of fifteen tractor-trailer trucks

who brought a products liability action against the engine manufacturer, alleging that

the 0.5 nitrous oxide engines were defective. Id. at 138. Our sister court concluded

that the trial court did not its abuse discretion in ordering production of information

–9– concerning 0.2 engines, in addition to the 0.5 engines at issue, since both engines

utilized the same technology at issue. Id. at 142.

And in In re Caterpillar Inc., No. 09-13-00106-CV, 2013 WL 1932819 (Tex.

App.—Beaumont 2013, orig. proceeding) (per curiam) (mem. op.), also a products

liability suit, Emery Bowie died after a bulldozer moved unexpectedly in reverse.

Id. at *1. The plaintiffs sought documents related to another lawsuit brought against

Caterpillar by Alphonso Lopez concerning a wheel tractor scraper. Id. Caterpillar

objected to the request, arguing that the two machines involved different

transmissions, gears, speed controls, steering, and engines. Id. Also, Lopez was

injured while seated, while Bowie had been standing. Id. But, because there was

evidentiary support that the Lopez accident was caused by a problem involving the

electrical control system, and the allegedly defective Caterpillar machine in the

Bowie case contained a similar system, our sister court of appeals concluded that the

plaintiffs were entitled to information about the electronic control system in the

Lopez suit. Id. at *1–2.1

1 This Court recently reiterated these principles in In re National Collegiate Athletic Ass’n, 543 S.W.3d 487, 496 (Tex. App.—Dallas 2018, orig. proceeding). In that case, plaintiff Debra Ploetz brought a wrongful death action against the NCAA for negligence, alleging that her husband Greg’s death from Chronic Traumatic Encephalopathy (CTE) was a result of concussions he sustained while playing college football. The NCAA argued that the trial court’s order to produce documents related to head trauma of all types from all sports was overbroad. We rejected the argument that the order should be limited to injuries sustained solely while playing football, because “[i]nformation known to the NCAA regarding concussive and non-concussive blows to the head and the impact of those injuries on NCAA athletes is discoverable regardless of whether the NCAA obtained the information from studying brain injuries in soccer players, hockey players, football players, or athletes in other sports because the injury, not the sport, is the proper inquiry.” Id. At issue in this lawsuit is the danger presented by the generator, and if and when Relator became aware of this danger; how it became aware of the danger, whether it acquired such knowledge because of problems attendant to transcutaneous or percutaneous procedures, is of no significance. –10– As shown in these cases, discovery in a products liability case need not be

limited to the same product so long as there is a connection to the alleged defect.

The case before us presents an even stronger argument because the allegedly

defective product—the generator—is the same for the percutaneous and

transcutaneous procedures. Thus, there is an obvious connection. Further,

recognizing the differences between the two procedures, the trial court sensibly

directed Relator to produce a narrower field of discovery for the transcutaneous

procedures, requiring only “complaints” instead of the “complete investigation file”

that must be produced for the percutaneous procedures. Accordingly, we conclude

that the trial court did not abuse its discretion in permitting discovery for both

procedures.

3. Injuries occurring after date of Plaintiff’s injuries

Lastly, Relator asserts the trial court’s order is overbroad in that it “concerns

injuries which occurred after the date of [Plaintiff’s] injury.” Again, we cannot

agree. In her third amended petition, Plaintiff alleged Relator placed into the stream

of commerce the radio frequency device, i.e., the ThermiRF generator that is the

subject of this litigation, and the device was unreasonably dangerous and defective

at the time of the incident. Thus, discovery of injuries involving that product’s

temperature-related problems, whether occurring before or after the Plaintiff’s

injuries, is potentially relevant to this allegation and, at a minimum, is reasonably

–11– calculated to lead to the discovery of admissible evidence. See TEX. R. CIV. P.

192.3(a). Thus, no abuse of discretion is shown here.

Conclusion

We conclude the trial court abused its discretion only to the extent it failed to

limit the subject matter of the discovery to adverse events involving the ThermiRF

System generator’s temperature-related problems. Accordingly, we conditionally

grant the petition for writ of mandamus in part and direct the trial court to modify its

order consistent with this memorandum opinion. The trial court’s modified order is

due within thirty days of the date of this opinion. The writ will issue only in the

event that the trial court fails to comply.

/Amanda L. Reichek/ AMANDA L. REICHEK JUSTICE

200246F.P05

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