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Thursday, April 21, 2011 01:12 Central 085628.014100 MOTIONMEMFIND 2005 WL 3133302 385 1 0

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2005 WL 3133302 (S.D.Tex.)

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For Opinion See 2005 WL 6000500 , 2005 WL 6000501 United States District Court, S.D. Texas, Corpus Christi Division. Oscar A. GARCIA, v. David A. MCFARLING, M.D.; et al. Civil Action No. 04-555. October 31, 2005. Jury Demanded Defendants, David McFarling, M.D., et.al. and Michael Gieger, M.D., et.al.'s Daubert Challenge and Motion to Exclude Expert Testimony TO THE HONORABLE JUDGE OF SAID COURT: COME NOW, DAVID McFARLING, M.D., INDIVIDUALLY AND IN HIS ASSUMED OR COMMON NAME; NEUROLOGY, P.A.; NEUROLOGY, P.A. D/B/A THE NEUROLOGICAL CLINIC; THE NEUROLOGICAL CLINIC, IN ITS ASSUMED OR COMMON NAME; MICHAEL GIEGER, M.D., INDIVIDUALLY AND IN HIS ASSUMED OR COMMON NAME; AND NEUROSURGERY INSTITUTE OF SOUTH TEXAS, P.A., INDIVIDUALLY AND IN ITS ASSUMED OR COMMON NAME, Defendants in the above entitled and numbered cause, and do hereby make and file this their Daubert Challenge and Motion to Exclude Expert Testimony, and in thereof would respectfully show unto this Honorable Court the following: I. Basis of the Daubert Challenge 1. This is a medical malpractice case involving allegations that negligent management on the part of numerous Defendants in the management of a 41 year old man following the surgical implantation of an intrathecal morphine pump resulted in his paralysis. Plaintiff designated Scott A. Shapiro, M.D., a neurosurgeon from Indianapolis, Indiana, as a medical expert on both liability and causation. However, Dr. Shapiro's causation opinion is unreliable, and therefore, should be excluded. Plaintiff also designated and produced the reports of J. Antonio Aldrete, M.D and Michael Foley, M.D. These witnesses were subsequently de-designated. To the extent that any of Dr. Aldrete's opinions or conclusions will be offered into evidence or utilized in this case, Defendants would show the Honorable Court that he is unqualified and his opinions are unreliable. To the extent that any of Dr. Foley's opinions or conclusions will be offered into evidence or utilized in this case, Defendants would show the Honorable Court that he is unqualified and his opinions are unreliable. Additionally, Plaintiffs deposed Horatio Aldredge, M.D., a neurology healthcare provider. To the extent that any of Dr. Aldredge's opinions or conclusions on causation will be offered into evidence or utilized in this case, Defendants would show the Honorable Court that he is unqualified and his opinions are unreliable. 2. On or about September 21, 2005, Plaintiff designated Dr. Shapiro pursuant to Fed. R. Civ. P. 26(2)(a) and

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produced his report (Exhibit 1) and curriculum vitae (Exhibit 2). Thereafter, on October 24, 2005, Defendants took the deposition of Dr. Shapiro to further discover the bases for his liability and causation opinions. At deposition, Dr. Shapiro explained that it is his opinion that inflammatory mass lesion cells invaded the spinal cord and ”“ ate ‘’ it, causing the release of chemicals and leading to the occlusion of small blood vessels, which ultimately caused Plaintiff's paralysis. (Exhibit 3 at pages 57, 58, 70, 82-84 and 142). This phenomenon described by Dr. Shapiro is uned in the relevant medical community as it is has not been tested, is not a generally accepted, and reaches an unfounded conclusion. Therefore, it is unreliable and should be excluded. Moreover, Dr. Shapiro has failed to demonstrate he is properly qualified to offer expert opinions within the field of neuroradiology. 3. Dr. Aldredge testified, over objection, that the most likely cause of Mr. Garcia's problems was the morphine or the chemicals that buffered the morphine itself. (Exhibit 8 at page 55). However, he also testified that he only is familiar with the effects of morphine on the spinal cord as an analgesic and that he is unaware of any complications associated with morphine being directly applied to the spinal cord. (Exhibit 8 at page 58-59). As a result, Dr. Aldredge's opinion that the problems were caused by the morphine is unreliable because, by his own testimony, he has no scientific or factual basis for this opinion. II. Daubert and Federal Rules of Evidence 702 4. Under FRE 702, an expert's opinions must be sufficiently reliable for ission into evidence. The court is empowered to make a pretrial evaluation of whether an expert's opinion is issible because it lacks a reliable foundation in the expert's discipline. Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 592-93 (1993). To satisfy the reliability test, Daubert and FRE 702 require that: (1)the expert's testimony be based on sufficient facts or data; (2)the expert's testimony be the product of reliable principles and methods; and (3)the expert apply the principles and methods reliably to the facts of the case. 5. In the case before this Honorable Court, there is no data or factual basis to Dr. Shapiro's opinion as to causation, other than the mere fact that Plaintiff is currently paralyzed. The same is true for Dr. Aldredge's opinion regarding the cause of Mr. Garcia's problems. Dr. Shapiro and Dr. Aldredge did not provide any studies or medical literature with his report or at the time of their depositions to this opinion. In short, there is no data, study or literature to his opinion, other than the fact that Dr. Shapiro claims this unfounded phenomenon to be true. This is, however, insufficient as the Supreme Court has pointed out ”“ nothing in either Daubert or the Federal Rules of Evidence requires a district court to it opinion evidence that is connected to existing data only by the ipse dixit of the expert.‘’ Kuhmo Tire Co. v. Carmichael, 526 U.S. 137, 157 (1999). III. Dr. Shapiro's Causation Opinion Fails to Satisfy the Daubert Factors of Reliability 6. The Supreme Court in Daubert enunciated factors that a Court should consider when evaluating the reliability of the expert's opinions. These four (4) factors are as follows: (1)whether the theory or technique underlying the expert's testimony can be or has been tested. Daubert, 509 U.S. at 593 (2)the known or potential rate of error of the technique and the existence and maintenance of standards con-



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trolling the technique's operation. Daubert, 509 U.S. at 594 (3)whether the theory or technique has been subjected to peer review and publication. Daubert, 509 U.S. at 593 (4)whether the expert's theory or technique enjoys ”“ general acceptance ‘’ within a relevant scientific community. Daubert, 509 U.S. at 594 7. Dr. Shapiro's causation opinion that that inflammatory mass lesion cells invaded the spinal cord and ”“ ate ‘’ it, causing the release of chemicals and leading to the occlusion of small blood vessels, which ultimately caused Plaintiff's paralysis has not been tested or proven. Dr. Shapiro has come forth with no evidence that he has conducted any studies or analyses to substantiate this opinion. See Wheat v. Pfizer, Inc., 31 F.3d 340, 343 (5th Cir. 1994) (medical causation opinion properly excluded where no study on the combined effect of drugs had ever been performed, and thus expert's hypothesis lacked an empirical foundation). Moreover, this theory has not been subjected to peer review and no medical literature, study, or other medical data has been published to substantiate Dr. Shapiro's opinion. In addition, Dr. Shapiro's opinion has not been ”“ generally accepted ‘’ within the medical or scientific community. Accordingly, Dr. Shapiro's opinion fails to satisfy the reliability factors as set forth in Daubert, and therefore, should be excluded. IV. Dr. Shapiro's Causation Opinion Also Fails to Satisfy Other Reliability Factors 8. In Kuhmo Tire Co. v. Carmichael, the Supreme Court stated that the trial court can consider other factors to ensure that the expert ”“ employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field. ‘’ Kuhmo, 526 U.S. at 137. Some of these factors that have been recognized are as follows: (1)whether the expert's opinion was developed expressly for the purpose of testifying or as the result of independent research. See Metabolife Int'l, Inc. v. Wornick, 264 F.3d 832, 841 (9th Cir. 2001) (2)whether the expert has unjustifiably extrapolated from an accepted premise to an unfounded conclusion. See General Electric v. er, 522 U.S. 136, 146 (1997) (3)whether the expert has adequately ed for alternative explanations. See Munos v. Orr, 200 F.3d 291, 301 (5th Cir. 2000) 9. Dr. Shapiro's causation opinion before this Honorable Court was not generated as the result of independent research. As stated previously, there has been no literature, study, or other empirical data to his opinion. In addition, there is too great an analytical gap between the medical data in this case and Dr. Shapiro's opinion as to the cause of Plaintiff's paralysis. Dr. Shapiro's opinion can be tested, but, simply put, it has not. As such, an analytical gap exists that is too great to bridge. The mere existence of a temporal relationship between the treatment measures employed by these Defendants and Plaintiff's resulting paralysis, without more, renders Dr. Shapiro's conclusions unreliable. This Honorable Court has previously articulated this very premise: The ”“analytical gap‘’ between the Phillips study and Dr. Polukoff's conclusion is simply too great. See Moore, 151 F.3d at 277. The strong temporal relationship between Mr. Brumley's first use of Viagra and his sudden death, without more, does not make Dr. Polukoff's opinion any more reliable. Curtis v. M & S Petroleum. Inc., 174 F.3d 661, 670 (5th Cir. 1999) (temporal connection standing alone is entitled to little weight). The Court concludes that Dr. Polukoff's opinion simply is not ed by any real world observations or experimental scrutiny. Although Dr. Polukoff may have identified an area of real concern and an avenue for fruitful study, he has not demonstrated that his opinion is reliable in the sense required to make it issible.



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Brumley v. Pfizer, Inc., 200 F.R.D. 596, 602 (S.D. Tex. 2001) V. The Causation Opinion of Dr. Shapiro and Dr. Aldredge is Ipse Dixit and Fails to Exclude Other Causes 10. Moreover, Dr. Shapiro and Dr. Aldredge have not adequately ed for alternative explanations for Plaintiff's paralytic condition. Under Texas law, the plaintiff must exclude with reasonable certainty other potential causes of his medical condition. E.I. du Pont de Nemours & Co. v. Robinson, 923 S.W.2d 549, 559 (Tex. 1995) (expert's opinion that a herbicide applied to trees must have been contaminated, without any testing to exclude other causes, was unreliable, and therefore, rendering the opinion little more than speculation). If there are other plausible causes of the injury or condition that could be negated, the plaintiff must offer evidence excluding those causes with reasonable certainty. Merrell Dow Pharmaceuticals v. Havner, 953 S.W.2d 706, 720 (Tex. 1997) (expert's failure to exclude other causes of birth defect contributed to finding that causation opinion was unreliable). 11. Furthermore, an ”“ expert's bald assurance of validity is not enough. ‘’ Daubert v. Merrell Dow Pharms., Inc., 43 F.3d 1311, 1316 (9th Cir. 1995) (upon remand); Havner, 953 S.W.2d at 711. The United States Supreme Court firmly grounded this principle in General Electric Co. v. er stating: [N]othing in either Daubert or the Federal Rules of Evidence requires a district court to it opinion evidence which is connected to existing data only by the ipse dixit of the expert. A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered. General Electric Co. v. er, 522 U.S. 136, 146 (1997). 12. This was again reiterated by the United States Supreme Court in Kuhmo (”“nothing in either Daubert or the Federal Rules of Evidence requires a district court to it opinion evidence that is connected to existing data only by the ipse dixit of the expert.‘’). Kuhmo, 526 U.S. at 137. Well before the advent of Daubert, er, and Kuhmo, the Fifth Circuit recognized that it is not so simply because ”“ an expert said it is so. ‘’ Viterbo v. Dow Chem. Co., 826 F.2d 420, 421 (5th Cir.1987). When the expert brings to court ”“ little more than his credentials and a subjective opinion, ‘’ it is not evidence that would a judgment. Id. at 421-22. In Viterbo, the Fifth Circuit affirmed a summary judgment and the exclusion of expert testimony on the basis that was unreliable, holding that ‘’[i]f an opinion is fundamentally uned, then it offers no expert assistance to the jury. ‘’ Id. at 422. The Fifth Circuit further endorsed this rationale in rejecting the view that an expert's opinions can avoid scrutiny under Daubert merely because they are based on his experience and training. Watkins v. Telsmith, Inc., 121 F.3d 984, 991 (5th Cir. 1997). The same principle is true of Robinson and the Texas Rules of Evidence: ”“[I]t is not so simply because “an expert says it is so' ‘’. Havner, 953 S.W.2d at 712. VI. Dr. Shapiro is Not Qualified to Offer Expert Opinions in the Field of Neuroradiology or Neurology 13. Dr. Shapiro has also offered himself as an expert in the field of neuroradiology. However, he has not demonstrated the requisite qualification in this specific medical discipline to establish he is qualified to interpret imaging studies and offer competent opinions and conclusions thereafter. 14. Under both Federal and Texas law, in order to offer expert testimony, an expert must be qualified to give an



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opinion as an expert ”“ by knowledge, skill, experience, training or education. ‘’ Fed. R. Evid. 702; Tex. R. Evid. 702. In determining whether an expert is qualified, trial courts must ensure that those who purport to be experts truly have expertise concerning the actual subject matter about which they are offering an opinion. Roberts v. Williamson, 111 S.W.3d 113, 121 (Tex. 2003); Broders v. Heise, 924 S.W.2d 148, 153 (Tex. 1996). Witnesses who do not demonstrate they are qualified to offer testimony about certain subject matter are properly excluded from testifying. 15. Texas law has added requirements that must be satisfied for an expert to be considered qualified to render opinion in a medical negligence case. Tex. Rev. Civ. Stat. Ann. art. 4590i §14.01 (a) provides that: [A] person may qualify as an expert witness on the issue of whether the physician departed from accepted standards of medical care only if the person is a physician who: (1)is practicing medicine at the time such testimony is given or was practicing medicine at the time the claim arose; (2)has knowledge of accepted standards of medical care for the diagnosis, care, or treatment of the illness, injury, or condition involved in the claim; and (3)is qualified on the basis of training or experience to offer an expert opinion regarding those accepted standards of medical care. 16. In determining whether the expert is qualified on the basis of training and experience, the court is to consider whether, at the time the claim arose or the testimony is given, the witness is board certified or has other substantial training or experience in an area of practice relevant to the claim and is actively practicing medicine in rendering medical care services relevant to the claim. Id. at §14.01 (c). Because of the increasing specialization of medicine, ”“ there is no validity, if there ever was, to the notion that every licensed medical doctor should be automatically qualified to testify as an expert on every medical question ... [t]he proponent of the testimony has the burden to show that the expert “possesses special knowledge as to the very matter on which he proposes to give an opinion.' ‘’ Broders, 924 S.W.2d at 152-53. 17. Dr. Shapiro has not demonstrated adequate qualifications in the field of neurosurgery that would qualify him as an expert. Dr. Shapiro is not board certified in radiology. His curriculum vitae does not reflect that he has any substantial training or experience as it pertains to the interpretation of diagnostic imaging studies. Neither does his curriculum vitae reflect any substantial training or experience as it pertains to neurology and/or the routine management and dosing of intrathecal morphine pumps. In fact, Dr. Shapiro acknowledged that he relies on an anesthesiology trained physician to manage the few intrathecal morphine pumps he has inserted. Therefore, his opinions in this regard should be excluded because he is unqualified by training or experience to render expert testimony regarding the dosaging of the morphine. (Exhibit 3 at page 125). In short, Dr. Shapiro's curriculum vitae and his deposition testimony are insufficient to qualify him as an expert in the field of neuroradiology or neurology. VII. The Consulting Expert Opinions of Dr. J. Antonio Aldrete and Michael Foley, M.D. Should Also be Excluded 18. At the time of his Federal Rules of Civil Procedure 26 Disclosures and designation of experts, Plaintiff also designated Dr. J. Antonio Aldrete, an anesthesiologist from Birmingham, Alabama and Dr. Michael Foley, a radiologist from Florida. Dr Aldrete's report (Exhibit 4) and curriculum vitae (Exhibit 5) and Dr. Foley's report (Exhibit 6) and curriculum vitae (Exhibit 7) were produced. Since the time of that designation, Plaintiff has de-



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designated Dr. Aldrete and Dr. Foley as expert witnesses. However, to the extent that Dr. Aldrete's and Dr. Foley's report or the opinions and conclusions contained therein are to be used or relied on by testifying experts, Defendants assert that Dr. Aldrete and Dr. Foley are not qualified to render opinions critical of Dr. Gieger or Dr. McFarling. Specifically, Dr. Aldrete does not practice as a neurosurgeon, neurologist, or neuroradiologist. He is not board certified in neurosurgery, neurology, or radiology and is not a member of any professional associations in these fields. He does not perform surgery, does not implant morphine pumps, and has not demonstrated any specialized training or experience that would otherwise qualify him to render opinions relative to the procedure to implant the pump. Moreover, Dr. Aldrete has not shown adequate qualifications to express opinions on the nature of Plaintiff's neurologic impairment. Statements as to the permanency and degree of Plaintiff's condition exceed the scope of his qualifications. Further still, Dr. Aldrete has failed to demonstrate that, based on his training and experience, he is properly qualified to interpret imaging studies. Lastly, Dr. Aldrete has not shown the necessary education or experience to express an opinion as to causation in this case. Dr. Foley is not a neurosurgeon or neurologist. He does not perform surgery, implant morphine pumps, and has not demonstrated any specialized training or experience that would otherwise qualify him to render opinions relative to the procedure to implant or manage the pump. As a result, any opinions rendered by Dr. Foley regarding further investigation or removal of the pump should be excluded on the basis that he is not qualified to render such opinions. 19. Moreover, similar to Dr. Shapiro, Dr. Aldrete has failed to exclude other causes of Plaintiff's paralytic condition. Although not qualified in the field of neuroradiology, Dr. Aldrete concludes in his report that there was a granuloma ”“ compressing the spinal cord ‘’ which required an emergency laminectomy to remove it. (Exhibit 4 at page 11). It was this granuloma ” “ compressing the spinal cord ‘’ that, Dr. Aldrete opines, ultimately lead to Plaintiff's current medical condition. Curiously, this opinion on causation is different to plaintiff's other expert, Dr. Shapiro. (However, Dr. Aldrete fails to exclude other potential causes of Plaintiff's paralysis. In order to adequately for alternative explanations of Plaintiff's paralytic condition, Dr. Aldrete was required to exclude other possible causes. He has not done so. 20. A District Court for the Southern District of Texas (Houston Division) has previously struck Dr. Aldrete's opinion, found him to be unqualified, and excluded his testimony. In the unreported case of Copley v. Smith & Nephew, Inc., 2000 W.L. 223404 (S.D. Tex. 2000), Plaintiff sued a product manufacturer claiming that an internal fixation device used in spinal fusion surgeries to provide stability to the affected vertebrae and facilitate fusion was defective. Id. at *1. Plaintiff claimed that the defective product caused him to suffer post-implant back conditions such as pain and numbness. Id. at *2-3. Plaintiff retained Dr. Aldrete as an expert witness, who offered the opinion that the implantation surgery caused Plaintiff's conditions. The trial court found that Dr. Aldrete's opinion lacked reliability and failed to demonstrate the causal relationship between the surgery/device and Plaintiff's condition. In so finding, the court stated that [t]here is no evidence that Dr. Aldrete attempted through any means to exclude other potential causes of Plaintiff's medical condition. Instead, it appears from the record that Dr. Aldrete simply adopted the opinion that he was paid to provide. ‘’ Id. at *4. The court concluded that ”“ Dr. Aldrete's opinion that the implant surgery caused Plaintiff's post-implant condition lacks adequate indicia of reliability.‘’ Id. at *5. 21. In this case, Dr. Aldrete has failed to establish that he is qualified to offer expert opinions in the field of neurosurgery, neurology, and neuroradiology. Similar to Copley, Dr. Aldrete did not exclude other potential causes of Plaintiff's condition and his opinion lacks adequate indicia of reliability. As such, his report and any opinion contained therein should be excluded. VIII.



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Conclusion and Request for Relief 22. Dr. Shapiro's causation opinion that inflammatory mass lesion cells invaded the spinal cord and ”“ ate ‘’ it, causing the release of chemicals and leading to the occlusion of small blood vessels, which ultimately caused Plaintiff's paralysis, is uned by any literature, study, or other empirical data. It is untested, unproven, has not been subjected to peer review, and is not generally accepted within the relevant medical or scientific community. It is not based on sufficient facts or data and is not the product of reliable principles. Moreover, it is uned and rests on the mere ipse dixit of the expert himself. As such, it cannot be considered as competent, reliable evidence under the principles of Daubert and Fed.R.Evid. 702. Further still, Dr. Shapiro has not demonstrated that he is qualified to render opinions on issues of neuroradiology. Accordingly, his opinions should be excluded in accordance with the foregoing. Likewise, Dr. Aldrete, Dr. Foley and Dr. Aldredge have not shown they are qualified to render opinions in this case and also failed to exclude other causes of Plaintiff's condition. As such, Dr. Aldrete's and Dr. Foley's report and their opinions and conclusions should also be excluded. Similarly, Dr. Aldredge's opinions regarding the cause of the ” “problems‘’ should be excluded. END OF DOCUMENT



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