9-18-2012 - Motion - Strike CV - DC0902215 - 10480787 - MOTION - STRIKE September 18, 2012 (2024)

 
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 Filed 12 September 18 P5:04 Gary Fitzsimmons District Clerk Dallas District CAUSE NO. 09-02215 GABRIELA SAENZ ROBINSON, as next § IN THE DISTRICT COURT Friend of RUBEN PINALES, § Plaintiff, § vs. § OF DALLAS COUNTY, TEXAS § JORGE FABIO LLAMAS-SOFORO, M.D.; § JORGE FABIO LLAMAS-SOFORO, M.D., P.A., § D/B/A EL PASO EYE CARE CENTER; § LUIS ALBERTO AYO, M.D.; PEDIATRIX § MEDICAL GROUP OF TEXAS, P.A.; § PEDIATRI MEDICAL GROUP, INC.; ROY § JOHN CAVIGLIA, M.D.; FORTUNATO § PEREZ-BENAVIDES, M.D.; JOSE § BERNARDO ARLLANO, M.D.; AND § VIBHA HONKAN, M.D., § Defendants. § 160th JUDICIAL DISTRICT DEFENDANTS LUIS ALBERTO AYO, M.D., ROY JOHN CA VIGLIA, M.D., FORTUNATO PEREZ-BENAVIDES, M.D., JOSE BERNARDO ARELLANO, M.D., PEDIATRIX MEDICAL GROUP OF TEXAS, P.A. AND PEDIATRIX MEDICAL GROUP, INC.'S OBJECTIONS TO AND MOTION TO STRIKE CAUSATION OPINIONS AS UNRELIABLE TO THE HONORABLE JUDGE OF SAID COURT: COME NOW, Defendants Luis Alberto Ayo, M.D., Roy John Caviglia, M.D., Fortato Perez-Benavides, M.D., Jose Bernardo Arellano, M.D., Pediatrix Medical Group of Texas, P.A. and Pediatrix Medical Group, Inc. ("Neonatology Defendants") and fie their Objections to and Motion to Strike Causation Opinions as Unreliable, and would respectfully show the Cour as follows: I. BACKGROUND Because Plaintiff s causation theories are not scientifically reliable under the standards DEFENDANTS LUIS ALBERTO A YO, M.D., ROY JOHN CA VlGLIA, M.D., FORTUNATO PEREZ-BENAVIDES, M.D., JOSE BERNARDO ARELLANO, M.D., PEDIATRIX MEDICAL GROUP OF TEXAS, P.A. AN PEDIATRIX MEDICAL GROUP, INC's OBJECTIONS TO AND MOTION TO STRIKE CAUSATION OPINIONS AS UNELIABLE - Page 1 918.0140/479963.1 required by Tex. R. Evid. 702, the Neonatology Defendants now move to strike Plaintiffs causation testimony by their experts. Plaintiff s pediatric ophthalmology expert Wiliam Good, M.D. provides some opinions on causation along with, to a lesser extent, her neonatology expert Marcus Hermansen, M.D. The Neonatology Defendants contend Dr. Hermansen is not qualified to provide causation opinions, and Plaintiff should not be allowed to improperly refer to his opinions, be it directly or indirectly. i Dr. Good's causation opinions establish, at best, a loss of chance for Ruben Isaia Pinales. Such claims are not recognized in Texas; therefore, these opinions are based on an improper legal standard and are likewise unreliable. Moreover, Dr. Good does not exclude other plausible causes of Ruben Isaia's vision problems, and the failure to do so renders Dr. Good's testimony inadmissible under the standards set out in Havner. Plaintiff canot segregate her damages (as is their burden under Texas law). The Neonatology Defendants respectfully request that the Cour, in its fuction as gatekeeper, exclude such opinions from evidence before the trier of fact. II. ARGUMENTS & AUTHORITIES A. Expert Testimony Must Be Reliable. Texas Rule of Evidence 702 provides that "if scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or determine a fact in issue, a witness qualified as an expert by knowledge, skil, experience, training, or education may testify thereto in the form of an opinion or otherwise." TEx. R. EVID. 702. The standard for determining IDr. Hermansen's few statements on causation are the same as Dr. Good, so references to Dr. Good's opinions are also a direct challenge to Dr. Hermansen's opinion should the Cour rule he is qualified to testify in this regard. DEFENDANTS LUIS ALBERTO A YO, M.D., ROY JOHN CA VlGLIA, M.D., FORTUNATO PEREZ-BENAVIDES, M.D., JOSE BERNARDO ARELLANO, M.D., PEDIATRIX MEDICAL GROUP OF TEXAS, P.A. AND PEDIATRIX MEDICAL GROUP, INC.'S OBJECTIONS TO AND MOTION TO STRIKE CAUSATION OPINIONS AS UNRELIABLE - Page 2 918.0140/479963.1 what wil assist the trier offact has become more stringent as scientific evidence conflcts and expert witnesses disagree. In order to avoid having cases decided on testimony which is nothing more than conjecture or speculation, the Texas Supreme Cour and Texas Legislature have promulgated a set of standards that establish what constitutes legally sufficient evidence and appropriate expert testimony. See, e.g., TEx. CiV. PRAC. & REM. CODE AN. §§ 74.401, 74.403; E.l Du Pont de Nemours & Co. v. Robinson, 923 S.W.2d 549, 556 (Tex. 1995); Merrell Dow Pharm., Inc. v. Havner, 953 S.W.2d 706, 712 (Tex. 1997). Expert witness testimony is "uneliable if it is not grounded in methods and procedures of science and is no more than subjective belief or unsupported speculation." Couch v. Simmons, 108 S.W.3d 338, 341 (Tex. App.-Amarilo 2003, no pet.). The Texas Supreme Cour in Robinson ariculated six non-exclusive factors that the trial cour may consider in determining the reliabilty of expert opinions: (1) the extent to which the theory has been or can be tested; (2) the extent to which the technique relies upon the subjective interpretation of the expert; (3) whether the theory has been subjected to peer review and/or publication; (4) the technique's potential rate of error; (5) whether the underlying theory or technique has been generally accepted as valid by the relevant scientific community; and (6) the non-judicial uses which have been made of the theory or technique. Robinson, 923 S.W.2d at 557. In cases where not all of the Robinson factors are applicable, it is proper for the trial cour to consider whether there is too great of an "analytical gap" between the DEFENDANTS LUIS ALBERTO A YO, M.D., ROY JOHN CA VIGLIA, M.D., FORTUNATO PEREZ-BENAVIES, M.D., JOSE BERNARDO ARELLANO, M.D., PEDIATRIX MEDICAL GROUP OF TEXAS, P.A. AND PEDIATRIX MEDICAL GROUP, INC.'s OBJECTIONS TO AND MOTION TO STRIKE CAUSATION OPINIONS AS UNRELIABLE - Page 3 918.0140/479963.1 data and the expert's testimony. See id. at 726; see also Havner, 953 S. W.2d at 727; Exxon Pipeline Co. v. Zwahr, 88 S.W.3d 623,629 (Tex. 2002). Even in cases in which the cour does not utilize these six factors to assess expert reliability, the expert must stil explain the bases for opinions and how those observations support the ultimate conclusion. Gammil, 972 S.W.2d at 727-28. In Merrell Dow Pharm., Inc. v. Havner, 953 S.W.2d 706, 712 (Tex. 1997), the Supreme Cour added a "foundation test" to the reliability and relevancy analysis spelled out in Robinson. Havner, 953 S.W.2d at 714. That is, an expert's opinion must be based on sufficient "underlying facts or data" and wil be inadmissible if the opinion is based on unreliable foundation evidence. Id Moreover, the Havner Cour cited Robinson and explained that, to surive a legal suffciency review, the plaintiff must offer evidence that excludes other "plausible" causation scenarios, to a reasonable degree of certinty. Id at 720. Finally, in Gammil, the Supreme Cour held that the rules governing admissibilty of expert testimony should not differ due to the fact that the evidence is considered novel or unconventionaL. Gammil, 972 S.W.2d at 721. In this regard, when considering "non- scientific" experts who base their opinions on observation and experience, such opinions that fail the "analytical gap" test should be stricken. Id at 727-728. That is, an expert's testimony is inadmissible if the expert fails to show how his observations support his conclusions. Id at 726. For instance, if the expert brings only his credentials and subjective opinion, his testimony is unsupported and therefore of no assistance to the jur. Id Cours are also willng to strike experts due to uneliability where an expert's opinion is based on assumed facts that var materially from the actual, undisputed facts. Burroughs Wellcome Co. v. Crye, 907 S.W.2d 497,500 (Tex. 1995). DEFENDANTS LUIS ALBERTO A YO, M.D., ROY JOHN CA VIGLIA, M.D., FORTUNATO PEREZ-BENAVIDES, M.D., JOSE BERNARDO ARELLANO, M.D., PEDIATRIX MEDICAL GROUP OF TEXAS, P.A. AND PEDIATRIX MEDICAL GROUP, INC.'S OBJECTIONS TO AND MOTION TO STRIKE CAUSATION OPINIONS AS UNLIABLE - Page 4 918.0140/479963.1 Before Plaintiff may present Dr. Good or Dr. Hermansen's testimony, the Cour must exercise its duty as a gatekeeper and determine whether the testimony is reliable. See Robinson, 923 S.W.2d at 556; see also TEx. R. EVID. 703. Plaintiffs causation theories do not pass muster. B. Dr. Hermansen is Not Qualifed to Discuss Causation. Although Dr. Hermansen at times mentions causation and Plaintiff may try to elicit same, he is not qualified to opine as to whether Isaia's injuries were a proximate result ofthe Neonatology Defendants' alleged negligence. See Dr. Hermansen's deposition, page 55, line 19 - page 56, line 13. Dr. Hermansen did not produce any literature, studies, or reliable bases for his opinion, nor could he provide any in his deposition. C. Dr. Good's Opinion Regarding Plus Disease Is Without Foundation. Dr. Good offers the opinion that Isaia must have reached threshold during the time Dr. Llamas was out of town. This means that Isaia had to develop plus disease in at least 5 contiguous clock hours of Stage 3 disease. Dr. Good bases his opinion on his belief that Dr. Hernandez described bilateral retinal detachments, meaning Isaia had a poor structural outcome. This opinion is without scientific basis. First, for a child to need treatment in 2000, he had to have plus disease - dilation and tortosity of the areries and veins of the retina. It is undisputed that according to the medical records, Isaia never had plus disease. Dr. Good then hypothesizes that Isaia developed plus disease in the 25 day period from 8/31 to 9/25 and that the plus disease disappeared in that period of time. He bases this on data from CRYO-ROP and ETROP showing the median time for plus disease. 100 DEFENDANTS LUIS ALBERTO A YO, M.D., ROY JOHN CA VIGLIA, M.D., FORTUNATO PEREZ-BENAVIDES, M.D., JOSE BERNARDO ARELLANO, M.D., PEDIATRIX MEDICAL GROUP OF TEXAS, P.A. AND PEDIATRIX MEDICAL GROUP, INC.'S OBJECTIONS TO AN MOTION TO STRIKE CAUSATION OPINIONS AS UNELIABLE - Page 5 918.0140/479963.1 10 Q. Tell me every basis for your opinion that he 11 developed at least five clock hours of Stage II 12 disease and plus disease in the time period between 13 August 31 st and September 25th. 14 A. I base it on what we know about the timing of 15 the development of ROP, and that's in one of those 16 aricles I produced. I believe that on the basis of 17 the finding of cicatricial changes, that characteristic 18 time as ROP is progressing, serious ROP is progressing, 19 documented by Dr. Llamas. And that was in October. 20 And my opinion is also based -- this is where 21 I think he had retinal detachments. It's also based on 22 the fact that on many occasions, he was documented as 23 having very, very low vision. And that's consistent 24 with retinal detachments and, to a probability, having 25 gone through threshold disease. Second, for a child to need treatment, he needed at least 5 consecutive hours of Stage 3 disease. Dr. Good again relies on the CRYO-ROP and ETROP median data to support his opinion. Dr. Good has never seen a child develop plus disease and 5 consecutive hours of Stage 3 disease and have it disappear completely during this age range, either in his private practice or in any clinical trial or aricle. Isaia would literally be the first such child ever to have disease behave this way. 101 6 Q. Okay. Now, you mentioned that one of the 7 aricles talked about the timing of development in ROP. 8 Which aricle were you talking about? 9 A. It's the incidence paper. It's right on top. 10 Q. That's Exhibit 21? 11 A. 21. Uh-huh. 12 Q. All right. And what portion of that aricle 13 are you relying on for that purose? 14 A. So there's a Table 5. And Table 5 compares 15 the CRYO-ROP study with the ETROP study and describes 16 the average age at which infants developed Stage I, 17 Stage II, Stage II, and plus disease. And it was 18 quite similar comparing both studies. DEFENDANTS LUIS ALBERTO A YO, M.D., ROY JOHN CA VlGLIA, M.D., FORTUNATO PEREZ-BENAVIDES, M.D., JOSE BERNARDO ARLLANO, M.D., PEDIATRIX MEDICAL GROUP OF TEXAS, P.A. AND PEDIATRIX MEDICAL GROUP, INC.'s OBJECTIONS TO AND MOTION TO STRIKE CAUSATION OPINIONS AS UNLIABLE - Page 6 918.0140/479963.1 The median data on which Dr. Good relies deals with onset of plus disease and Stage 3 disease. The Table 5 shows that plus disease had its median onset at 36.3 weeks post conceptual age (PCA) and that Stage 3 disease had its median onset at 36.6 weeks PCA. Isaia was 37.5 weeks PCA on 9/25. Dr. Good literally has no evidence that Isaia could have developed plus disease and Stage 3 disease in that time frame and had plus disease completely disappear while the stage 3 disease worsened. He has no evidence that his theory is scientifically reliable. D. Dr. Good Cannot Establish an Absolute Benefit from Treatment that is Greater than 50%; as such, Plaintiffs' Proximate Cause Argument is Based on Loss of Chance. In order to establish the element of proximate cause, Plaintiff must demonstrate that more likely than not, the proposed treatment (including timing, natue of treatment, etc.) would have avoided the damage claimed. The Texas Supreme Court repeatedly has rejected the "loss of chance" argument - that a patient who had a chance of a better outcome should be allowed to recover. Unless the patient had a greater than 50% chance of avoiding the claimed damage, that patient may not recover damages in Texas. The best that can be said about Dr. Good's opinions is that they amount to a "loss of chance claim." Such claims are not recognized in Texas; therefore, the opinions are based on an improper legal standard and are likewise uneliable. According to the published literatue, 45% of babies with ROP who are treated timely go on to have visual acuity less that 20/200 (legally blind). Dr. Good canot establish, based on personal experience, scientific literature or any other reliable basis that Ruben Isaia had a greater than 50% chance of good visual acuity based on anything Dr. Llamas did DEFENDANTS LUIS ALBERTO A YO, M.D., ROY JOHN CA VlGLIA, M.D., FORTUNATO PEREZ-BENAVIDES, M.D., JOSE BERNARDO ARELLANO, M.D., PEDIATRIX MEDICAL GROUP OF TEXAS, P.A. AND PEDIATRIX MEDICAL GROUP, INC.'s OBJECTIONS TO AND MOTION TO STRIKE CAUSATION OPINIONS AS UNELIABLE - Page 7 918.0140/479963.1 or failed to do. He merely opines that there would have been a difference in outcome with timely treatment; no one can show what the difference in outcome is when the damage is already (to use Plaintiffs word) irreversible. Dr. Good's testimony is solely based on loss of chance, not on science or expenence. To prevail on a medical negligence cause of action, the plaintiff must prove four elements. Plaintiff must prove that the treating physician has a duty to act according to an applicable standard of care, a breach of that standard of care, injur resulting from that breach, and a causal connection between the breach and the injur. Schorlemer v. Reyes, 974 S.W.2d 141, 147 (Tex. App.-San Antonio 1998, pet. denied). The Supreme Cour addressed claims of lost chance of recovery in Kramer v. Lewisvile, in which it determined that the ultimate standard of proof on causation is whether the negligent act or omission is a substantial factor in bringing about the har and without which the har would not have occured. Kramer, 858 S.W.2d at 400. This standard must be established by a preponderance of the evidence. Id. The effect of this standard of proof is "to bar recovery where the defendant's negligence deprived the tort victim of only a 50% or less chance of avoiding the ultimate har." !d. In Kramer, the Cour determined that there is no liabilty in Texas for negligent medical treatment that decreases a patient's chance of avoiding har when the har most probably would have occured regardless of the negligence. Park Place Hasp. v. Estate of Milo, 909 S.W.2d 508 (Tex. 1995). The Cour also rejected all versions of and variations on the loss of chance doctrine, including "the increased risk of har theory." Marvell v. Alston, 100 S.W.3d 460, 481 (Tex. App.-Fort Worth 2003). The Fort Worth Cour of Appeals in Marvell went on to clarify: DEFENDANTS LUIS ALBERTO A YO, M.D., ROY JOHN CA VIGLIA, M.D., FORTUNATO PEREZ-BENAVIDES, M.D., JOSE BERNARO ARELLANO, M.D., PEDIATRIX MEDICAL GROUP OF TEXAS, P.A. AND PEDIATRIX MEDICAL GROUP, INC.'s OBJECTIONS TO AND MOTION TO STRIKE CAUSATION OPINIONS AS UNRELIABLE - Page 8 918.0140/479963.1 "Evidence of an increased risk of har, as one version of the loss of chance theory, is not legally suffcient evidence if the risk would not be increased to a probability of greater than fift percent." Id. Thus, Plaintiffs claims are bared unless Dr. Llamas' actions caused Plaintiff to have less than 50% chance of recovery. In Kramer, the Supreme Court determined that, in a medical malpractice claim, there is no liabilty for "negligent treatment that decreases a patient's chance of avoiding death or other medical conditions in cases where the adverse result probably would have occured anyway." Id. The Cour goes on to state: Unless cours are going to compensate patients who 'beat the odds' and make full recovery, the lost chance canot be proven unless and until the ultimate har occurs. Hence, legal responsibility under the loss of chance doctrine is in reality assigned based on the mere possibilty that a tortfeasor's negligence was a cause of the ultimate har. Id. at 404 (emphasis in original). Under Texas law a plaintiff must establish a probability of more than 50% that a defendant's negligence in a medical malpractice case caused the loss or har that Plaintiff alleges. Here, Plaintiff has no plausible causation theory against the Neonatology Defendants. Moreover, even assuming somehow the Neonatology Defendants should and could have altered Dr. Llamas' decision makng in this case, Plaintiff canot establish, as a matter of law, that Dr. Llamas actions or inactions caused Isaia's risk of a poor visual outcome by more than 50%. Some basic and undisputed science is helpful to the analysis. Of all prematue babies who develop ROP, 94% never need treatment for their disease. DEFENDANTS LUIS ALBERTO A YO, M.D., ROY JOHN CA VlGLIA, M.D., FORTUNATO PEREZ-BENAVIDES, M.D., JOSE BERNARDO ARELLANO, M.D., PEDIA TRIX MEDICAL GROUP OF TEXAS, P.A. AN PEDIATRIX MEDICAL GROUP, INC.'S OBJECTIONS TO AND MOTION TO STRIKE CAUSATION OPINIONS AS UNELIABLE - Page 9 918.0140/479963.1 42 3 Q. And so put another way, 94 percent of the 4 babies who actually had ROP never needed treatment, 5 right? 6 A. I think that's correct. See Exhibit "B," Deposition of Dr. Good, page 42, lines 3-6. The treatment for ROP, which consists of destruction of the avascular retina with either laser or cryotherapy, caries significant risk to the child. As such, the child must have a certain severity of disease (called "threshold" disease) before the benefit of treatment outweighs the risk: 37 19 Q. Back in 2000, when Isaia Pinales was being 20 treated for his premature birth, there was a term 21 called "threshold for treatment of ROP," correct? 22 A. Yes. 23 Q. And there were certin criteria which we'll 24 get into later, but the threshold was a certain degree 25 of severity ofROP at which point it was deemed 38 1 appropriate to provide ablative treatment, correct? 2 A. Correct. Id at page 37, Line 19 - Page 38, Line 2. Moreover, since such a large percentage of children who have ROP never need treatment, unecessar surgery should be avoided unless the strict criteria for treatment are met, and the child has threshold disease. 42 7 Q. And certainly, you do not ever want to 8 endanger a child by performing unnecessar surgical 9 treatment, true? 10 MR. RAEY: Objection. Form. 11 THE WITNESS: Well, as stated by you, yeah, 12 that's true. DEFENDANTS LUIS ALBERTO A YO, M.D., ROY JOHN CA VIGLIA, M.D., FORTUNATO PEREZ-BENAVIES, M.D., JOSE BERNARO ARELLANO, M.D., PEDIATRIX MEDICAL GROUP OF TEXAS, P.A. AND PEDIATRIX MEDICAL GROUP, INC.'s OBJECTIONS TO AND MOTION TO STRIKE CAUSATION OPINIONS AS UNELIABLE - Page 10 918.0140/479963.1 Id at page 42, Lines 7-12. The goal oftreatment was to avoid, if possible, retinal detachment at the back, or posterior, portion of the retina. 49 2 Q. The unavorable outcome definition that we 3 just used of posterior retinal detachment, retinal fold 4 involving the macula, or retrolental tissue obscuring 5 the posterior pull. 6 A. I don't know if that's true, because I haven't 7 looked at those papers. 8 Q. All right. If that is, indeed, the result of 9 those papers, you don't disagree with their findings, I 10 take it? 11 MR. RAMEY: Objection. Form. 12 THE WITNESS: Well, no, I don't. If that, 13 indeed, is applicable papers. Id. at page 49, Lines 2-13. At the time ofIsaia's treatment, a large randomized clinical trial (known as CR YO- ROP) set out the benchmark by which ophthalmologists determined when a child had a favorable outcome from their ROP or when they had an unavorable outcome. These benchmarks applied whether the child had treatment or did not. The study demonstrated that while there was a benefit to treatment in children whose disease was at threshold, that benefit was not more than 50%. In fact, there was only a 21.9% improvement in structual outcomes with treatment as opposed to those eyes which did not receive treatment. 173 13 Q. All right. Well, the treated eyes, even with 14 treatment by the best docs at the best institutions, 15 had an unfavorable structual outcome 30 percent of the 16 time 15 years later, didn't they? DEFENDANTS LUIS ALBERTO A YO, M.D., ROY JOHN CA VlGLIA, M.D., FORTUNATO PEREZ-BENAVIES, M.D., JOSE BERNARDO ARELLANO, M.D., PEDIATRIX MEDICAL GROUP OF TEXAS, P.A. AN PEDIATRIX MEDICAL GROUP, INC.'s OBJECTIONS TO AND MOTION TO STRIKE CAUSATION OPINIONS AS UNRELIABLE - Page 11 918.0140/479963.1 17 A. Yes. 18 Q. The control or untreated eyes had an 19 unfavorable structual outcome 51.9 percent of the 20 time? 21 A. Point to me where you're looking. 22 Q. (Indicating.) 23 A. That's correct. 24 Q. And if we do the subtraction, the difference 25 between the eyes that were treated and the eyes that 174 1 received no treatment at all is 21.9 percent with 2 respect to structual outcome, isn't it? 3 A. Yes. See Exhibit "B" at page 173, line 13 -- page 174, line 3. Even in looking at visual acuity, eyes which received treatment only had a favorable visual outcome 19.6% more of the time than did the eyes which received not treatment. 174 4 Q. Okay. And if we go to the right and look at 5 the colums under "Unfavorable Visual Acuity Outcomes," 6 we note that the treated eyes at 15 years had an 7 unfavorable visual acuity of 44.7 percent? 8 A. Correct. 9 Q. And the control or untreated eyes had an 10 unfavorable visual acuity outcome of 64.3 percent? 11 A. Correct. 12 Q. A real difference of 19.6 percent, correct? 13 A. Correct. DEFENDANTS LUIS ALBERTO AYO, M.D., ROY JOHN CAVIGLIA, M.D., FORTUNATO PEREZ-BENAVIDES, M.D., JOSE BERNARO ARELLANO, M.D., PEDIATRI MEDICAL GROUP OF TEXAS, P.A. AND PEDIATRIX MEDICAL GROUP, INC.'S OBJECTIONS TO AND MOTION TO STRIKE CAUSATION OPINIONS AS UNRELIABLE - Page 12 918.0140/479963.1 Id at page 174, lines 4-13. Even had Isaia undergone treatment as alleged by the Plaintiff, his ability to improve either structural outcome or his visual outcome was only about 20% (a range of 19.6-21.9%). More likely than not, then, based on the evidence, Isaia's outcome could not have been improved to a reasonable degree of medical probabilty. As such, Plaintiff canot prove an essential element of their claim-that the Defendants proximately caused injur to a reasonable degree of medical probability. Plaintiffs only expert concedes that the only available evidence at the time shows that even with timely and appropriate treatment, the outcomes were not improved more than 50% of the time. The Fort Worth Cour of Appeals expressly relied on the data in the CRYO-ROP study in holding that an expert's testimony on causation in an ROP case, which testimony was inconsistent with the results of the CRYO-ROP study, lacked scientific foundation and should not have been admitted by the trial court. See Gross v. Burt, 149 S.W.3d 213, 230-241 (Tex.App. - Fort Worth 2004, pet. denied). The same is true here: Dr. Good's opinions on causation lack any scientific basis and are inconsistent with the admitted findings of the CRYO-ROP study. Therefore, they provide no evidence of proximate cause because they completely lack factual foundation. With respect to ROP, the only large prospective randomized trial evaluating treatment versus nontreatment of ROP was the "Multicenter Trial of Cryotherapy for Retinopathy of Prematuity" ("CRYO-ROP"). The CRYO-ROP Trial is the best available data on the benefit ofROP treatment, according to Plaintiffs own ophthalmology expert, Dr. Good. 46 9 Q. The CRYO-ROP study was the only large DEFENDANTS LUIS ALBERTO A YO, M.D., ROY JOHN CA VlGLIA, M.D., FORTUNATO PEREZ-BENAVIDES, M.D., JOSE BERNARDO ARELLANO, M.D., PEDIATRIX MEDICAL GROUP OF TEXAS, P.A. AND PEDIATRI MEDICAL GROUP, INC.'S OBJECTIONS TO AND MOTION TO STRIKE CAUSATION OPINIONS AS UNRELIABLE - Page 13 918.0140/479963.1 10 perspective randomized clinical trial evaluating 11 treatment versus nontreatment of ROP that was available 12 at the time ofIsaia's care in 2000, right? 13 A. I believe that's correct, yes. 177 7 Q. Have any similar epidemiologic studies to 8 CRYO-ROP been performed to study the benefit of 9 treatment versus no treatment? 10 A. No. 11 Q. And is it your belief and opinion that no such 12 study wil ever be done because it would likely be 13 unethical and not pass the requisite ethics panels to 14 implement such a study? 15 A. Yes, it would be unethicaL. 16 Q. SO this date is the best we've got on the 17 benefit of treatment? 18 A. Yes. See Exhibit "B" at page 46, lines 9-13 and page 177, lines 7-18. CRYO-ROP studied the efficacy of cryotherapy. 165 23 Q. Okay. CRYO-ROP was an attempt to determine 24 whether or not treatment for threshold retinopathy of 25 prematurity was effcacious? 166 1 A. Correct. Id at page 165, line 23 - page 166, line 1. The subjects of the Multicenter Trial were followed and re-evaluated at three-and-a-halfyears, five-and-a-halfyears, ten years, and fifteen years. 172 5 Q. And you note that at 3 and a half, 5 and a 6 half, 10 years, and 15 years these babies were 7 restudied to see how much better the treated eye was DEFENDANTS LUIS ALBERTO A YO, M.D., ROY JOHN CA VIGLIA, M.D., FORTUNATO PEREZ-BENAVIDES, M.D., JOSE BERNARDO ARELLANO, M.D., PEDIA TRIX MEDICAL GROUP OF TEXAS, P.A. AND PEDIATRIX MEDICAL GROUP, INC.'s OBJECTIONS TO AND MOTION TO STRIKE CAUSATION OPINIONS AS UNRELIABLE - Page 14 918.0140/479963.1 8 fuctioning versus the untreated eye? 9 A. Yes. Id at page 172, lines 5-9. The most recent follow-up of CRYO-ROP discusses and identifies the outcomes of eyes that received treatment, as well as eyes that did not receive treatment. 171 24 Q. Doctor, Exhibit 31 is, I wil represent to 25 you, a Table 3 from the Archives of Ophthalmology, 172 1 March of2005, which is a sumar of the structual and 2 visual acuity outcomes for the CRYO-ROP babies. 3 Does this look familiar to you? 4 A. It does. 5 Q. And you note that at 3 and a half, 5 and a 6 half, 10 years, and 15 years these babies were 7 restudied to see how much better the treated eye was 8 fuctioning versus the untreated eye? 9 A. Yes. 10 Q. And to the best of your recollection of the 11 medical statistics and data, does Table 3 accurately 12 state the difference in structural and visual acuity 13 outcome for the treated versus control eye for the 14 cohort? 15 MR. RAMEY: Objection. Form. 16 THE WITNESS: It does. It does. Id at page 171, line 24 - page 172, line 16. The results of this study are ilustrated in "Table 3" of attched Exhibit "C" and reproduced below: DEFENDANTS LUIS ALBERTO A YO, M.D., ROY JOHN CA VIGLIA, M.D., FORTUNATO PEREZ-BENAVIES, M.D., JOSE BERNARDO ARELLANO, M.D., PEDIATRIX MEDICAL GROUP OF TEXAS, P.A. AND PEDIATRI MEDICAL GROUP, INC.'S OBJECTIONS TO AND MOTION TO STRIKE CAUSATION OPINIONS AS UNELIABLE - Page 15 918.0140/479963.1 Abr8: CAYOOP, liuI Trl ci Cl)er 10 ReUnohy of Pr. "Vues II øll as perc_ft. fRonvlal~no mein 111 Yl. $l HO Raii Vl8U Ac1i11y Te used. §A,u for dJsitna fòp mes (see ""p!lll~an "Vsu Acult subse 01 "R8S Slcton). As can be seen from the results in Table 3, treatment provides at most a 21.9% increase in avoiding an unfavorable structural outcome and a 19.6% increase in avoiding an unfavorable visual acuity outcome. These results, at their highest, are a far cry from the minimum "greater than 50%" standard that Texas law requires. In other words, for Plaintiff to prove causation in her case, she is required to show that treatment would have provided more than a 50% improvement in likelihood that Isaia would have avoided his outcome, compared to no treatment at all. As can clearly be seen, treatment only provides approximately a 20% improvement in likelihood that Isaia would have avoided his outcome. Plaintiff s own expert conceded that the benefit of treatment only provides approximately 20% benefit. DEFENDANTS LUIS ALBERTO A YO, M.D., ROY JOHN CA VlGLIA, M.D., FORTUATO PEREZ-BENAVIDES, M.D., JOSE BERNARDO ARELLANO, M.D., PEDIATRI MEDICAL GROUP OF TEXAS, P.A. AND PEDIATRIX MEDICAL GROUP, INC.'S OBJECTIONS TO AN MOTION TO STRIKE CAUSATION OPINIONS AS UNRELIABLE - Page 16 918.0140/479963.1 172 10 Q. And to the best of your recollection of the 11 medical statistics and data, does Table 3 accurately 12 state the difference in structual and visual acuity 13 outcome for the treated versus control eye for the 14 cohort? 15 MR. RAMEY: Objection. Form. 16 THE WITNESS: It does. It does. 17 BY MR. SCHELL: 18 Q. You know, it occurs to me that there is a 19 remarkable consistency in the difference between the 20 favorable and unfavorable structural outcomes of the 21 treated and control eyes over this 15-year period. 22 Did you note that? 23 A. There is a consistency, yes. 24 Q. I mean, it's within, what, about two 25 percentage points? 173 1 A. Or so, uh-huh. 2 Q. Okay. And what this means, if we go to the 3 15-year last time the cohort was studied, is that there 4 is a 21.9 percent relative benefit of treatment from a 5 structual outcome standpoint. 6 A. I'm not sure I agree entirely with how you've 7 expressed that, but there is a difference of 8 29.1 percent. 9 Q. How would you express it? 10 A. There is a difference of21.9 percent between 11 those eyes that were maintained as controls and those 12 that were treated. 13 Q. All right. Well, the treated eyes, even with 14 treatment by the best docs at the best institutions, 15 had an unfavorable structual outcome 30 percent of the 16 time 15 years later, didn't they? 17 A. Yes. 18 Q. The control or untreated eyes had an 19 unavorable structual outcome 51.9 percent of the 20 time? 21 A. Point to me where you're looking. 22 Q. (Indicating.) DEFENDANTS LUIS ALBERTO A YO, M.D., ROY JOHN CA VlGLIA, M.D., FORTUNATO PEREZ-BENAVIDES, M.D., JOSE BERNARO ARELLANO, M.D., PEDIATRIX MEDICAL GROUP OF TEXAS, P.A. AND PEDIATRIX MEDICAL GROUP, INC.'S OBJECTIONS TO AND MOTION TO STRIKE CAUSATION OPINIONS AS UNRELIABLE - Page 17 918.0140/479963.1 23 A. That's correct. 24 Q. And if we do the subtraction, the difference 25 between the eyes that were treated and the eyes that 174 1 received no treatment at all is 21.9 percent with 2 respect to structural outcome, isn't it? 3 A. Yes. 4 Q. Okay. And if we go to the right and look at 5 the colums under "Unfavorable Visual Acuity Outcomes," 6 we note that the treated eyes at 15 years had an 7 unavorable visual acuity of 44.7 percent? 8 A. Correct. 9 Q. And the control or untreated eyes had an 10 unfavorable visual acuity outcome of 64.3 percent? 11 A. Correct. See Exhibit "B", page 172, line 1 0 to page 174, line 11. It is incumbent on Plaintiff to establish that the extent epidemiologic data addressing the efficacy ofROP therapy supports a greater than 50% probabilty of an improved visual outcome with treatment. It is undisputed that had Isaia been treated, he would have only had a 20% chance of avoiding his injuries, according to the only data available on this matter. i Plaintiff fails to provide suffcient evidence of causation as a matter of law. Plaintiff s claims amount to nothing more than "loss of chance" claims, and such claims are impermissible under Texas law. Were Plaintiff to dispute the outcome data from CRYO-ROP, Plaintiff would need an expert to have offered a timely opinion on what the difference in outcome would have been, to a reasonable degree of medical probabilty, and then provide the scientific basis for that opinion. Plaintiff s only expert on outcomes, Dr. Good, failed and declined to offer any such opinion in either his report or i This is assuming Isaia's eyes ever reached a treatable state, which all defendants contend never occured. DEFENDANTS LUIS ALBERTO A YO, M.D., ROY JOHN CA VlGLIA, M.D., FORTUNATO PEREZ-BENAVIES, M.D., JOSE BERNARO ARELLANO, M.D., PEDIATRIX MEDICAL GROUP OF TEXAS, P.A. AND PEDIATRIX MEDICAL GROUP, INC.'S OBJECTIONS TO AND MOTION TO STRIKE CAUSATION OPINIONS AS UNRELIABL 

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