Opinion issued November 19, 2020

In The 

## Court of Appeals For The 

## First District of Texas

———————————— NO. 01
- 20
- 00146
- CV

—— ————————— TEXAS CHILDREN ’S HOSPITAL , Appella nt

V. AVIV BARR AND ELA BARR, INDIVIDALLY AND AS NEXT FRIENDS

OF M . B . , A MINOR CHILD , A pp ellees
On Appeal from the 189th District Court

Harris County, Texas Trial Court Ca se No. 2019
- 12365

MEMO RANDUM OPINION Appellees, Aviv Barr and Ela Barr, individually and as next friends of M.B., a minor child, sued Texas Children’s Hospital (TCH) an d others for negligence in2

connection with a brain surgery performed on M.B. 1 After several objections and subsequent amendments to t he Barrs ’ expert report, TCH moved to dismiss the
Barrs ’ claims , arguing that their amended expert report was insufficient as to causation. The trial court denied the motion to dismiss. In its sole issue, TCH argues that the trial court abus ed its discretion in denying TCH’s objections to the amended expert report and motion to dismiss. Because we conclude that the expert affi da v it was sufficient, we affirm. Background The Barrs’ minor daughter, M.B., underwent a minimally

- invasive brain
surg ery to treat her epilepsy at TCH in Houston

. 2 On July 20, 2018, Dr. Daniel Curry performed the surgery at TCH using the NeuroBlate system, w h ich is an MRI

guided 3 laser ablation device that had been subject to a recall by the Food and Drug Administration ( FDA ) , prior to M.B.’s surgery, in October 2017 . M.B. was discharged from TCH on July 22, 2018, but she later experienced symptoms such as

1 The Barrs also sued Dr. Daniel Curry, the surgeon, and Monteris, the manufacturer of the ablation laser that allegedly malfunctioned, but they a re not parties to this appeal.

2 We accept the facts included in Dr. Avellino’s report for the limited purpose of this appeal. See Marino v. Wilkins , 393 S.W.3d 318, 320 n.1 (Tex. App.

— Houston [1st Dist.] 2012, pet. denied); see also Bowie Mem ’ l Hosp. v

. Wright , 79 S.W.3 d 4 8, 53 (Tex. 2002) (review of Chapter 74 report is limited to four corners of report).

3 The NeuroBlate system used Magnetic Resonance Imaging to guide the surgeon’s use of the la ser probe.3

dizzin ess , vomiting , and loss of consciousness and was admitted to St. Mary’s Medical Center in Florida for further treat ment. Doctors at St. Mary’s concluded that M.B. had a ruptured pseudoaneurysm and treated her with additional surgery, and
M.B. was the n move d to a hospital in Tel Aviv, Israel for further rehabilitation. The Barrs allege that M.B. has suffered permanent b rain damage. The Barrs filed suit against TCH, Dr. Curry, and Monteris, the manufacturer of the NeuroBlate system. The Barrs alleged pr oduct

- liability claims against Monteris, and they alleged that Dr. Curry was negligent in several ways, including that he failed to disclose to the Barrs that the NeuroBlate system had been recalled by the FDA when he obtained their consent for the surg ery and that he failed to order vascular studies after M.B. first experienced a brain bleed during her surgery in July 2018 that wo uld have identified the pseudoaneurysm before its rupture. Finally, the Barrs alleged that TCH was negligent in permitting Dr . C urry to use i ts recalled NeuroBlate laser probe to perform M.B.’s surgery. The Barrs supported their pleadings with the expert r eport of Dr. Anthony Avellino, a pediatric and adult
neurosurgeon. 4 Dr. Avellino’s report , as amended to address deficiencies po inted out by TCH, provided details regarding the FDA’s recall of the NeuroBlate laser probe

. Dr.

4 The Barrs also provided an additional exp e rt report from an eng ineer regarding the malfunctioning of the laser probe, but that report is not relevant to this appeal.4

Avellino stated in his report t hat this recall was due to “unexpected heating and probe damage, which ‘could cause unanticipated heating of surrounding brai n t issue, or dam age the tip of the probe, and allow the CO2 cooling gas inside the probe to leak into the brain. ’ ” He stated that , on October 5, 2017, the device was the subject of a Class I recall by the FDA , which recommended that health care providers “ sho uld strongly consider treating patients using alternative procedures if available

. ” He also indicated that a Class I recall mea n t “by definition [the malfunctioning device] can cause death or serious injury.” Monteris likewise sent notices to healthcare pr oviders betwe en October and December 2017 about the unintentional heating and advised doctors to “take certain precautionary st eps to mitigate the risk to patients, including limiting MRI scans while the probe is in the patient.” However, on March 22, 2 018 , the FDA sub sequently provided a “Safety Alert , ” informing health care providers that the steps recommended by Monteris were “n ot sufficient to mitigate the risk of unintended laser probe heating.” On April 24, 2018, the FDA warned health care provider s “ that the MR th ermometry, which is used to monitor the changes in temperature at the laser ablation site, was potentially inaccur ate and may not account for continued spread of energy to the surrounding brain tissue.” Dr. Avellino further stated that the FD A stated in it s notice that several adverse events were associated with use of the NeuroBlate system : “neurological deficits, increased intracerebral edema or5

pressure, intracranial bleeding, and/or visual changes.” Monteris continued to work on designi ng a new laser probe for the NeuroBlate system that replaced the metal thermocouple with a new, non

- metallic fiber optic sensor, “thus eliminatin g any risk of unintended probe heating.” This design was submitted to the FDA on July 30, 2018, ten days after M.B .’s surgery. On November 8, 2018, the FDA notified healthcare providers that Monteris had received FDA clearance for the new probe and stat ed that the safety risks associated with the old probe remained. Regarding M.B.’s surgery specifical ly, Dr. Avellino review ed M.B.’s medic al records from TCH and noted that “[p]osto p erative head CT imaging on 7/21/2018 revealed a small amount of acute hemorrhage a t the lesion site, intraventricular hemorrhage, and subarachnoid hemorrhage in the ambient c istern with an ab normal irregular roun ded shaped focal lesion lateral to the ambient cistern suspicious for an aneurysm.” He noted that, despite this he ad CT, “the cranial vasculature was not evaluated with a head CT angiogram to rule out an aneurysm and n o explanation

was given for the hemorr hages outside the lesion bed.” Rather, Dr. Curry relied on imaging that showed the bleeding appeared to be resolvi ng, and M.B. was discharged . She later sought further treatment at St. Mary’s Medical Center after she

“ became comatose.” When M.B. was admit ted to St. Mary’s on August 7, 2018, “head CT imaging showed a large acute right temporal intracerebral hematoma w ith diffuse6

intraventricular hemorrhage, acute hydrocephalus, and uncal herniation.” She underwent emerg ency surgery to r educe the swelling in her brain, and further imaging revealed that she had a pseudoaneurysm, which was treated at St. Mary’s.
M.B. was then released for “further rehabilitation” to a hospital in Tel Aviv “with permanent neurologic sequelae .” Regarding the standard of care and breach with regard to TCH, Dr. Avellino stated in his report that a hospital like TCH “requires formulation and en forcement of adequate policies regarding the use of recalled medical devices in surgical procedures perf

ormed at its faci lity.” He stated the TCH breached the standard of care by permitting Dr. Curry to use the NeuroBlate system because “the device is subj ect to a Class I recall (which by definition can cause death or serious injury)” against FDA warnings an d advice that “he alth care providers s trongly consider treating patients with alternative procedures if available.” Dr. Avellino stated that alternative procedures were available at the hospital. Regarding the causal connection between the outlined breache s and M.B.’s inju ries and damages, Dr. Avellino opined: “The NeuroBlate laser probe used in [M.B.’s] surgery can cause unintended heating to surrounding brain tissue, damaging blood vessels in the brain and creating pseudoaneurysms. A pseudoaneurysm occurs when a blood ves sel wall is injured, and the leaking blood collects in the surrounding tissue.” He recounted the above

- listed facts regarding the7

FDA’s recall of the NeuroBlate lase r probe as facts relevant to the “General Causation” of M.B.’s injuries. He fu rther stated, “The NeuroBlate laser probe used in [M.B.’s] surgery caused unintended heating to surrounding brain tissue, damaging a blood vessel in her brain a nd creating a pseudoaneurysm ” that eventually ruptured. In addition to the information from the FDA that the NeuroBlate probe was recalled bec ause it was prone to overheating and the FDA notices that such overheating had been associated with brain bleeds i n other patients, Dr. Avellino sp ecifically identified Dr. Curry’s operative report . This report noted that d uring surgery, “there was an elem ent of abnormal MR thermography at this point, which scanning revealed to be a small intraventricular and cisterna l hemorrhage.” Dr. Avellino stated, “Therefore, according to his operative report, Dr. Curry not iced an abnor mal heating pattern during [M.B.’ s] surgery and discovered a bleed in her brain. Therefore, the recalled laser probe caused unintended overheating and blood vessel damage, resulting in a bleed during the surgery.” Dr. Avellino’s expert report further obser ved that “sixteen days after her discharge, [M.B.] suffered a massive right temporal bleed, the same region of the brain as her intraoperative blee d.” He stated, “ B ased on the defective nature of the recalled laser probe and the location of the second blee d, the ruptured pseudoaneurysm was caused by the unintended overheating of the laser probe during the laser ablation surgery.”8

Finally, Dr. Avel lino opined, If [TCH] had prevented Dr. Curry from using the recalled NeuroBlate laser probe at its facility du ring [M.B.’s] surgery, her resu lting injuries and damages would not have occurred. As previously discussed, the recalled NeuroBlate laser probe used in [M.B.’s] surgery caused unintended heating to surrounding brain tissue, damaging a blood vessel in the b rain and creating a pseudoaneur ysm that eventually ruptured. Thus, had [TCH] properly prevented Dr. Curry from using the NeuroBlate laser probe, [M.B.] would not have suffered her resulting injuries. It was foreseeable that permitting a phy sician to utiliz e a medical device subject to a Class I Recall would cause injury to patients, including [M.B.] Moreover, [M.B.’s] injury was foreseeable to [TC H], as the NeuroBlate laser probe had been recalled months earlier for unintended overheating of surrounding bra in tissue, which could (and did ) result in intracranial hemorrhage. TCH objected to Dr. Avellino’s amended expert report on the basis that it d id not provide an adequate opinion as to causation, and it moved to dismiss the Barrs’ suit agai nst it for failu re to provide an adequate exper t report. The trial court denied the motion to dismiss, and this appeal followed. Expert Report In its sole issue , TCH argues that the trial court erred in overruling its objection to Dr. Avel l ino’s expert rep ort as to causat ion and denying its motion to d ismiss. A. Standard of Review and Relevant Law Section 74.351 of the Texas Medical Liability Act (TMLA) provides tha t no medical negligence cause of action may proceed until the plaintiff has made a good

faith ef fort to demonstr ate that a qualified medical ex pert believes that a defendant’s9

conduct breached the applicable standard of care and caused the claimed injury. See
T EX
. C IV
. P RAC
. & R EM
. C ODE § 74.351( l ), (r)(6). “[T]he purpose of the expert report require ment is to weed out frivolous malpractice claim s in the early stages of litigation, not to dispose of potentially meritorious claims.” Abshire v. Christus
Hea lth Se. Tex. , 563 S.W.3d 219, 223 (Tex. 2018) (per curiam). An expert report is sufficient under the TMLA if it “ provides a fair summary of the expert ’ s opinions

. . . regarding applicable standards of care, the manner in which the care rendered

. . . failed to meet the standards, and the causal relationship between the failure and the injury.” T EX
. C IV
. P RAC
. & R EM
. C ODE § 74.351(r)(6); Abshire , 563 S.W.3d at 223. “Importantly, the trial court need only find that the report constitutes a ‘good faith effort’ to comply with the statutory requirements.” Abshire , 563 S.W.3d at 223 (citing T EX
. C IV
. P RAC
. & R EM
. C ODE § 74

. 351 ( l )); see also Am. Transiti onal Care C trs. of Tex., Inc. v. Palacios , 46 S.W.3d 873, 878 (Tex. 2001) (holding that courts l ook to report itself to determine whether it “represents a good

- faith effort to comply with the statutory defini tion of an expert report”). An expert report dem onstrates a “good faith effort” when it “(1) inform[s] the defendant of the specific conduct cal led into question and (2) provid[es] a basis for the trial court to conclude the claims have merit.” Abshire , 56 3 S.W.3d at 223 ( citing Baty v. Futrell , 543 S.W .3d 689, 693

– 94 (Tex. 2018)). A report “need not marshal all the claimant ’ s proof,” but “a rep ort that merely states the expert ’ s conclusions about the10

standard of care, breach, and causation” is insufficient

. Id. (quoting Pa lacios , 46 S.W.3d at 878

– 79) ; s ee also Miller v. JSC Lake Highlands Operations, LP , 536 S.W.3d 510, 517 (Tex. 2017) (per c uriam) (holding that expert report does not have to meet same requirements as evidence in summary judgment proceeding or at trial)

. Th e expert must explain the basis for his statements and link his conclusions to the facts. Bowie Mem ’ l Hosp. v. Wright , 7 9 S.W.3d 48, 52 (Tex. 2002)

.

“ We review a trial court ’ s decision to grant or deny a motion to dismiss based on the ade quacy of an exper t report for an abuse of discre tion. ” Abshire , 563 S.W.3d at 223. “A trial court abuses its discretion if it acts in an arbitrary or unreasonable manner without reference to any guiding rules or principles.” Wright , 79 S.W.3d at 52. As a c ourt reviewing ma tters committed to the trial co urt’s discretion, we may not substitute our own judgment for that of the trial court me rely because we would have ruled differently. I

d. ; see also Larson v. Downing , 197 S.W.3d 303, 304 (Tex. 2006) (per curia m) (holding that, w hen reviewing decisions that fall within trial court’s discretion, “[c]lose calls must go to the trial court” )

. In analyzing a report ’ s sufficiency under this standard, we consider only the information contained within the four corners o f the report. Wri ght , 79 S.W.3d at 52. We are al so mindful that expert

- report challenges are made at an early, pre

- discovery st age in the litigation.
See Baty , 543 S.W.3d at 697 & n.10 (rejecting argument that expert report was inadequate, concluding that expert report suf ficed “particularly in light of the11

purposes the report is intended to serve” at early stage in litigation, a nd stating “additional detail is simply not required at this stage of the proceeding”).
TCH a rgues that Dr. Avellino’s expert repo rt is insufficien t as to causation. An expert re port must set out “the causal relationship between the failure and the injury. ” T EX
. C IV
. P RAC
. & R EM
. C ODE § 74.351(r)(6); Abshire , 563 S.W.3d at 223. “A causal relationship is established by proof that the negligent act or omission constituted a substant ial factor in bringing about the harm and that, absent the act or omission, the harm would not have occurred.” Kline v. Leonard , No. 01

- 19

- 00323

- CV, 2019 WL 6904720, at *9 (Tex. App.

— Houston [1st Dist.] Dec. 19, 2019, pet. de nied) (mem. op.); Costello v. C hristus Santa Rosa Health Care Corp. , 141 S.W.3d 245, 249 (Tex. App.

— San A ntonio 2004, no pet.). For causation, the expert report must explain “how and why” the physician’s or healthcare provider’s breach pr oximately caused the plaintiff’s injury. Columbi a Valley Healthcare Sys., L.P. v. Zamarripa , 526 S.W.3d 453, 459

– 60 (Tex. 2017); Jelinek v. Casas , 328 S.W.3d 526, 536 (Tex. 2010) ( “It is not enough for an expert simply to opine that the defendant ’ s neglige nce caused the pl aintiff ’ s injury. The expert mu st also, to a reasonable degree of medical probability, explain how and why the negligence caused the injury.” )

. “In satisfying this ‘how and why’ requirement, the expert need not prove the entire case or acc ount for every kn own fact; the report is suffici ent if it makes ‘a good

- faith effort to explain, factually, how12

proximat e cause is going to be proven.’” Abshire , 563 S.W.3d at 224 (quoting Zamarripa , 526 S.W.3d at 460). Proximate cause has two components: (1) foreseeabili ty and (2) cause

- in

- fact.
Zamar ripa , 526 S.W.3d at 46 0 ; Kelly v. Ford , 543 S.W.3d 383, 390 (Tex. A pp.

— Houston [14th Dist.] 2018, pet. denied). A causation opinion must explain both foreseeability and cause

- in

- fact and provide a “straightfo rward link” betwe en the alleged breach of the st andard of care and the claimed injury. See Abshire , 563 S.W.3d at 225 ; Miller , 536 S.W.3d at 515; Zamarripa , 526 S.W.3d at 460 . The court’s role is to determine whether the expert has explained how the neglig ent conduct cause d the injury. Abshire , 563 S.W. 3d at 226. B. Analysis Dr. Avellino’s expert report states that TC H was negligent in permitting Dr. Curry to use the recalled laser probe during M.B.’s laser ablation surgery. Dr. Avellino opined that the laser probe

— which the F DA had indicated was prone to

o verheating and damaging tissue in the area around the probe

— ove rheated during M.B.’s surgery. To support this opinion, Dr. Avellino cited Dr. Curry’s operative report that “there was an element of abnormal MR thermography ” du ring the surgery, and he genera lly cited the FDA’s warning that “the MR thermometry which is u sed to monitor the changes in temperature at the laser ablation site, was potentially inaccurate and may not account for continued spread of ener gy to the13

surroun ding brain tissue.” He opined t hat the overheated probe damaged a nearby blood vessel, causing bleeding during surgery, as the FDA noted had happened in other cases when the probe overheated. This damage caused a pseudoaneurysm

— a type of w eakness in a bloo d vessel’s wall that “occurs wh en a blood vessel wall is injured, and the leaking blood collec ts in the surrounding tissue.” Dr. Avellino further opin ed that, although M.B.’s initial brain imagining after surgery was “suspicious for an ane urysm,” Dr. C urry relied on follow up scans that showed that the hemorrhages were resolving before he discharge d M.B. Dr. Curry did not evaluate the vessels with a “head CT angiogram” to rule out an aneurysm and “no explanation was given for the hemorrhage s outside the les ion bed.” Thus, the pseudoaneur ysm went undetected until it ruptured

— which Dr. Avellino noted was a “vascular emergency”

— and M.B. suffered neurological damage.
Dr . Avellino’s expert report sets out a chain of events that links TCH’s alleged negligence in a llow ing Dr. Curry to use the recalled NeuroBlate laser probe with damage that occurred d uring her surgery , which subsequently caused further damage when the pseudoaneurysm ruptured. See Abshire , 563 S.W.3d at 225. The expert report indicates that the injur y to M.B. was foreseeable to TCH. See Zamarripa , 526 S.W.3d at 46 0

. The FDA had recal led the NeuroBlate laser probe because it was prone to overheating and causing brain bleeds, and this was precisely the injury sustained by M.B. Dr . Avellino also set out facts necessary to establ ish the cause

- in

-14

fact element of proximate cause by assertin g that, but for TCH’s negligence in permitting Dr. Curry to use the recalled laser probe, it could not have overheated during M.B.’s surgery, damag ing her blood vessels an d causing the development of the pseudoaneurysm that later ruptured. See id. The tr ial court could reasonably have concluded that the report sets out “to a reasonable degree of medical probability

. . . how and why” TCH’s alleged

n egligence in allowing Dr . Curry to use the recall ed device to perform surgery caused an injury to the v essel in M.B.’s brain , which in turn caused the remainder of her injuries. See Jelinek , 328 S.W.3d at 536; Kline , 2019 WL 6904720, at *9 (providing t hat causal relationship is e stablished by proof that alleged negligence was substantial factor in bringin g about harm). TCH asserts that Dr. Avellino’s expert report is conclusory and merely states his unsupported opinion, and it argues that his conclusion s are impermissibly vague. S pecifically, it argues th at Dr. Avellino’s opinion fails to link his conclusi on that the probe overheated to the underlying facts and fails to explain h ow the overheating caused the bleed. TCH argues that Dr. Avellino “improperl y extrapolates” from Dr.
Cur ry’s operative report

— not ing abnormal MR thermography and an area of bleeding

— to support the conclusion that the NeuroBlate laser probe overheated and damaged surrounding brain tissue. TCH asserts, “Dr. Curry’s operative report does not say that the probe overheated; nor does it s ay that the abnormal MR15

thermography is evidence tha t the probe overheated.” TCH argues that Dr. Curry’s report stated that the abnormal temperature reading was caused by the brain bleed, which was “a kn own complication of laser ab lation surgery, irrespect ive of any overheating of the medical device.” This argument, however, misconstrues the requirements for expert reports. Dr. Avellino’s expert report was required to make “‘a good

- faith effort to explai n, factually, how proximate cause is going to be prov en.’” Abshire , 563 S.W.3d at 224 (quoting Zamarrip a , 526 S.W.3d at 460). He did that by stating that abnormal thermography indicated that the laser probe overheated, damaging surrounding brain tissue, wh ich eventually caused the re main der of M.B.’s injuries . The fact that Dr. Curry’s operative report does not expressly state that the laser probe overheated does not render Dr. Avellino’s conclusions insufficient. Nor does the fact that Dr. Curry

a ttributed the abnormal thermography t o a different cause render Dr. Avellino’s report conclusory. “An expert repo rt need not marshal all of the plaintiff’s proof necessary to establish causation at trial, and it need not anticipate or rebut all possible de fensive theories that may ultimately be presented to the trial court.” K line , 2019 WL 6904720, at *9; see Wrigh t , 79 S.W.3d at 52; Cornejo v. Hilgers , 446 S.W.3d 113, 123 (Tex. App.

— Houston [1st Dist.] 2014, pet. denied). TCH further argues that Dr. Avelli no’s report does not explain why the abnormal thermography is a n indication that the probe overheated or how this fact16

supports his conclusion that the overheated probe caused the interoperative bleed.
But Dr. Avellino’s expert report states that the probe was recalled because it had been kno wn to overheat, and the FDA had specifically warned healthcare providers that the MR thermography was potentially unreliable because it “may not account for continued spread of energy to the surrounding brain tissue.” He opined that thermography during M.B .’s surgery show ed “an abnormal heating pattern” in the region where the laser probe was being used, leading Dr. Curry to discover a bleed in M.B.’s brain. Rather than ruling out the possibility of a pseudoane urysm, which is caused when blood vessels are i njured, Dr. Curr y discharged M.B. , and the pseudoaneurysm subseq uently ruptured. These facts from the expert report allowed the trial court to determine that Dr. Avellino had explained how TCH’s negligent cond uct caused M.B.’s injury. See Abshire , 563 S.W. 3d at 226. TCH fu rther argues that Dr. Avellino’s expert report fails to explain how M.B.’s brain bleed caused a ruptured pseudoaneurysm eighteen days after surgery, asserting that he bases his opinion sole ly on the fact that the pseudoaneurysm was located in the same region of M.B.’s brain as the intraoperative bl eed, which “is pure ipse dixit .” Contrary to this assertion, however, Dr. Avellino’s report provides not only that the pseudoaneurysm was located in the same region of M.B.’s brain as the intraope rative bleed, but also that pseudoaneurysms are caused by in jury to blood17

vessel walls. He then explained that the laser probe overheated, damaged the surrounding blood vessels, causing a bleed. Dr. Avelli no’s expert report was required to provide some ba sis for proving that TC H’s act or omission proximately cause d M.B.’s injury. See Wright , 79 S.W.3d at 53; Scoresby v. Santillan , 346 S.W.3d 546, 556 (Tex. 2011) (“No particular words or formality are requir ed [in the expert report], but bare conclusions wi ll not suffice.”). With respect to causation, our role “is to determine whether the expert has explained how the negligent conduct caused the injury. Whether this explanation is believable should be litigat ed at a later stage of the proceedings.” Abshire , 563 S.W.3d at 226; see also Miller , 536 S.W.3d at 51 6

– 17 (stating that “whether [an expert’s opinion of applicable] standards appear reasonable is not relevant to the analysis of whether the expert’s opinio n constitutes a good

- faith effort” and that adequa te expert reports need not “meet the same requiremen ts as the evidence offered at summary judgment or trial).
Because Dr. Avellino explained how the alleged negligent conduct

— TCH’s providing a recalled devi ce with which it allowed Dr. Curry to perform M.B. ’s
surgery

— caused the d amage to the blood vessel in M.B.’s brain that resulted in the remainder of her injuries, we cannot conclude that the trial court abused its discretion in determining that the expert report satisfied the TMLA ’ s requirement to provide18

“the causal relationsh ip between the failure and th e injury.” See T EX
. C IV
. P RAC
. &
R EM
. C ODE § 74.351(r)(6); Abshire , 563 S.W.3d at 223. We overrule TCH’s sole issue. Conclusion We affirm the trial cour t’s order denying TCH’s motion to dismiss.

Richard Hightower Justice Panel co nsists of Chief Justice Radack and Justices Hightower and Adams.