755 F.Supp.2d 236 (D.Me. 2010), 1:09-cv-00656-JAW, Samaan v. St. Joseph Hosp.
|Citation:||755 F.Supp.2d 236|
|Opinion Judge:||JOHN A. WOODCOCK, JR., Chief Judge.|
|Party Name:||Anton K. SAMAAN, Plaintiff, v. ST. JOSEPH HOSPITAL, et al., Defendants.|
|Attorney:||John P. Flynn, III, Daniel G. Lilley, Law Offices, P.A, Portland, ME, for Plaintiff. James F. Martemucci, L. John Topchik, Germani Martemucci Riggle & Hill, Jeffrey D. Russell, Thomas V. Laprade, Lambert Coffin, Portland, ME, for Defendant.|
|Case Date:||December 21, 2010|
|Court:||United States District Courts, 1st Circuit, District of Maine|
ORDER ON DAUBERT HEARING
Following a December 9, 2010 Daubert hearing, the Court grants Dr. David Kaplan's motion to exclude the expert testimony of Dr. Ravi Tikoo concerning the consequences of the failure to administer tissue plasminogen activator (t-PA) to Anton K. Samaan within three hours of the onset of his stroke symptoms. The battle line in this motion is drawn on whether it is more likely than not Mr. Samaan would have benefited if he had received timely t-PA. The Court concludes it is not.
I. STATEMENT OF FACTS
A. Mr. Samaan's Stroke and Treatment at St. Joseph
On January 14, 2006, Anton K. Samaan boarded a flight in Milan, Italy to return to New York, New York after visiting his family in Egypt for the holidays. During the flight, Mr. Samaan got up from his seat and headed toward the plane's galley for a cup of tea. When Mr. Samaan reached the galley, he was confronted by a flight attendant who told him that " he appeared sick." Notice of Removal at Attach 2 ¶ 9 (Docket # 1), Compl. The flight attendant called for doctors on the plane, and at approximately 11:30 a.m., a doctor diagnosed him with " a likely stroke in progress." Id. ¶ 10. In accordance with the doctor's instructions, the pilot diverted the plane to the nearest airport. Id.
The plane landed in Bangor, Maine and Mr. Samaan reached the emergency department at St. Joseph Hospital not later than 12:40 p.m., where he was treated by emergency room physician David Kaplan, M.D. Id. ¶ ¶ 11, 15. Dr. Kaplan did not administer t-PA. Id. ¶ 11. Mr. Samaan has suffered " severe deficits as a result of the ischemic stroke he suffered on 01/14/06." Id. ¶ 13. He filed this suit against St. Joseph and Dr. Kaplan, alleging that Dr. Kaplan's failure to administer t-PA violated the standard of medical care and caused him severe damages. Id. ¶ 22.
B. Defendant's Motion in Limine and the Subsequent Procedural History
Mr. Samaan designated Dr. Ravi Tikoo, a neurologist, to testify as his expert. Dr. Tikoo has stated that " Dr. Kaplan's decision not to administer t-PA proximately caused [Mr. Samaan's] alleged injuries." Def. David Kaplan M.D.'s Mot. in Limine To Exclude Test. of Ravi Tikoo, M.D. at 2 (Docket # 26) ( Def.'s Mot. ). In response, Dr. Kaplan says that Dr. Tikoo's opinion is inadmissible because his methodology is flawed. Dr. Kaplan maintains that Dr. Tikoo's view that " a patient would have a 51 percent or better chance of improvement if he was given t-PA as opposed to being given none" does not meet Daubert scientific standards for admissibility.1 Id. at 3.
On October 14, 2010, the Court issued an order denying Dr. Kaplan's motion, and observing that it " would benefit from a greater understanding of the foundation for the experts' opinions and from more illuminating and less adjectival advocacy." Order on Mot. in Limine at 9 (Docket # 49). Responding to the Court's suggestion,
Dr. Kaplan moved for a Daubert hearing on the expert witness issue. Def. David Kaplan, M.D.'s Mot. for Recons. Of the Court's Order on his Mot. for Summ. J. or in the Alternative for a Daubert Hearing on the Admissibility of the Opinions of the Pl.'s Causation Expert (Docket # 53) ( Def.'s Daubert Mot. ). Mr. Samaan responded and Dr. Kaplan replied, and on November 15, 2010, the Court granted the motion for a Daubert hearing. Pl.'s Mem. in Opp'n to Def. Kaplan's Mot. for Recons., or in the Alternative, for Daubert Hearing (Docket # 65) ( Pl.'s Daubert Opp'n ); Def. David Kaplan, M.D.'s Reply to Pl.'s Opp'n to Mot. for Recons. Of the Court's Order on His Mot. for Summ. J. or in the Alternative for a Daubert Hearing on the Admissibility of the Opinions of the Pl.'s Causation Expert (Docket # 66); Order Granting Mot. for Daubert Hearing (Docket # 68) ( Def.'s Daubert Reply ). After consulting with counsel, the Court scheduled the Daubert hearing for December 9, 2010, following which the parties filed legal memoranda. Defs.' Supplemental Mem. on the Use of Absolute Risk Reduction Versus Odds Ratio in Causation Analysis (Docket # 88) ( Defs.' Supplemental Mem. ); Pl.'s Mem. Following Daubert Hearing (Docket # 89) ( Pl.'s Supplemental Mem. ).
C. Daubert Hearing
At the Daubert hearing, the two experts testified by split screen videoconference; they were not only projected into the courtroom, but were able to hear and see each other.
1. The National Institute of Neurological Disorders and Stroke (NINDS) Study
In 1995, the NINDS published a paper in The New England Journal of Medicine titled " Tissue Plasminogen Activator for Acute Ischemic Stroke." The experts agree that the NINDS Study is the gold standard for assessing the effectiveness of the administration of t-PA within three hours of the onset of stroke symptoms. In general, the NINDS Study concluded that some patients who received timely t-PA improved over patients who did not. In one table, for example, using a National Institute of Health Stroke Scale Standard (NIHSS), the percentage of patients who improved after t-PA ranges from a high of 38% to a low of 31% and the percentage of patients who improved with a placebo ranges from a high of 21% to a low of 20%. Based on simple subtraction, Dr. Kaplan urges the Court to conclude that a difference of ten to eighteen percent does not begin to reach the civil standard of more than 50%.
The proper way to view improvement from t-PA, however, is disputed by the parties. Dr. Tikoo expressed the view that the NINDs Study supported his view that the likelihood of improvement was greater than 50%; Dr. Nyquist rejected Dr. Tikoo's opinion and stated that although the NINDS Study demonstrated that some patients improved, the percentage was markedly less than 50%. If Dr. Tikoo is correct, it is more likely than not that Mr. Samaan would have improved if t-PA had been timely administered; if Dr. Nyquist is correct, the failure to administer t-PA to Mr. Samaan may have caused him to improve, but it is not more likely than not that it would have done so.
2. Examination of Dr. Tikoo
The hearing opened with testimony about Dr. Tikoo's background and experience. Dr. Tikoo's curriculum vitae (CV) confirmed that he had received an award from the NINDS, the institute that had performed the seminal NINDS Study. He testified that, in performing the research for the NINDS that led to that award, part of his job was to interpret data. Dr.
Tikoo said he relied on interpretive methodologies he used with the NINDS in forming his opinions in this case.
Consistent with his deposition testimony, Dr. Tikoo reiterated that he relied on the NINDS Study and noted that the NINDS Study showed at least 30% of ischemic stroke patients who received t-PA suffered minimal or no disability three months after the stroke. He emphasized that the criteria used to reach the 30% figure— minimal or no disability— were very stringent and that a more relaxed view of improvement would expand the percentage of patients who benefit from t-PA.
In forming his opinion, Dr. Tikoo said that he relied predominantly on a figure called the Global Odds Ratio, a ratio that measures the relative likelihood of an outcome between two groups. According to Dr. Tikoo, an odds ratio of 1.0 indicates an outcome is equally likely between two groups and an odds ratio of 1.5 indicates that an outcome is 50% more likely for one group than another. Dr. Tikoo testified that the Global Odds Ratio combined the results of four measures of post-stroke function: the Barthel Index, the Modified Rankin Scale, the Glasgow Outcome Scale, and the National Institute of Health Stroke Scale (NIHSS). He testified that the NINDS Study resulted in a Global Odds Ratio of 1.7 for patients who received t-PA versus those who did not. This figure, he said, supported his opinion that Mr. Samaan would have had a greater than 50% chance of a more favorable outcome if he had been administered timely t-PA.
Dr. Tikoo also cited a 2001 and a 2004 article from Stroke , a medical journal of the American Heart Association. He testified that the 2001 article examined the NINDS Study data and reanalyzed it to determine t-PA's efficacy in achieving partial improvement below the stringent criteria of the indices in the original study. Dr. Tikoo stated that the reanalysis showed that in addition to the patients who fully recovered, an additional 20 to 30% of patients receiving t-PA enjoyed partial improvement. He argued that those partial improvements should be considered in examining the efficacy of t-PA. He further testified that the 2004 article reanalyzed the NINDS data and found an odds ratio of 2.1.
Dr. Tikoo also cited the 2008 ECASS-III study, which tested whether the time window for administering t-PA after the onset of stroke symptoms should be expanded beyond its 3-hour guideline. He testified that the study showed that 52.4% of patients receiving t-PA more than 3 hours after onset of stroke symptoms had a favorable outcome while 45.2% in the placebo group had a favorable outcome. Dr. Tikoo testified that the odds ratio between the t-PA and placebo groups was 1.34.
Finally, Dr. Tikoo testified that in addition to the scientific studies, he had relied on his own clinical...
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