Samaan v. St. Joseph Hosp.

• Decision Date: 14 October 2010
• Docket Number: No. CV–09–656–B–W.,CV–09–656–B–W.
• Citation: 744 F.Supp.2d 367
• Parties: Anton K. SAMAAN, Plaintiff,v.ST. JOSEPH HOSPITAL, et al., Defendants.
• Court: U.S. District Court — District of Maine

744 F.Supp.2d 367

Anton K. SAMAAN, Plaintiff,

v.ST. JOSEPH HOSPITAL, et al., Defendants.

No. CV–09–656–B–W.

United States District Court, D. Maine.

Oct. 14, 2010.

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, Lambert Coffin Haenn, Portland, ME, for Defendant.

ORDER ON MOTION IN LIMINE

JOHN A. WOODCOCK, JR., Chief Judge.

Based on a relatively scant record, the Court denies Dr. David Kaplan's motion to exclude the expert testimony of Dr. Ravi Tikoo concerning the likely consequences of the failure to administer tissue plasminogen activator (t-PA) to the Plaintiff within three hours of the onset of his stroke symptoms.

I. STATEMENT OF FACTSA. 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.” Compl. ¶ 9 Attach 2 (Docket # 1). The flight attendant called for doctors on the plane, and at approximately 11:30 am, a doctor diagnosed him with “a likely stroke in progress.” Id. at ¶ 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 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 has 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. Ravi Tikoo, M.D.

1. The Defendant's Characterization of Dr. Tikoo's Opinion

Mr. Samaan designated Dr. Ravi Tikoo, a neurologist, to testify as an expert on his behalf.¹ Dr. Tikoo will opine that “Dr. Kaplan's decision not to administer t-PA proximately caused [Mr. Samaan's] alleged injuries.” Def. David Kaplan's Mot. in Limine To Exclude Test. of Ravi Tikoo, M.D. at 2 (Docket # 26) ( Def.'s Mot.). At his deposition, Dr. Tikoo “testified that the authoritative and definitive study, on the efficacy of t-PA to achieve better outcomes for ischemic stroke patients is the 1995 study titled ‘Tissue Plasminogen Activator for Acute Ischemic Stroke,’ by the National Institute of Neurological Disorders and Stroke (NINDS) t-PA Stroke Study Group.” Id.; See Attach. 1 (Docket # 26) (NINDS Study). Dr. Tikoo “confirmed not only that the NINDS study is the ‘generally accepted article’ in this area, but also that it is the basis for his conclusions in this case, and that there was nothing independent of the NINDS study that caused Dr. Tikoo to form the opinions that he did.” Def.'s Mot. at 2.

Dr. Tikoo confirmed that the NINDS Study “was a randomized, double blind, placebo-controlled study wherein a group of subjects was administered t-PA, and a separate control group was not given t-PA despite the fact that its constituents fell within the standard three-hour window for the administration of t-PA following the onset of ischemic stroke symptoms.” Id. He agreed that the NINDS Study “showed that when the results for the placebo group are compared to the results of the t-PA group, the percentage of ‘favorable outcomes' increased by 12 percent for the t-PA patients, indicating a 12 percent absolute increase in the number of patients that ended up with minimal or no disability from stroke as a result of receiving t-PA.” Id. at 2–3. Despite statistics to the contrary, Dr. Kaplan says that Dr. Tikoo's methodology was flawed for arriving at his opinion 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.” Id. at 3.

2. The Plaintiff's Characterization of Dr. Tikoo's Opinion

Although Mr. Samaan agrees that Dr. Tikoo relied on the NINDS Study, he presents a different view of Dr. Tikoo's opinion testimony. Dr. Tikoo notes that the conclusion of the NINDS Study was:

Despite an increased incidence of symptomatic intracerebral hemorrhage, treatment with intravenous t-PA within three hours of the onset of ischemic stroke improved clinical outcome at three months.

Pl.'s Mem. in Opp'n to Def. Kaplan's Mot. in Limine to Exclude Test. from Ravi Tikoo, M.D. at 5 (Docket # 30) ( Pl.'s Mem.). Dr. Tikoo explained that “the 1995 NINDS Study could not be considered an ‘absolute’ indicator, because the definitions employed to denote ‘improvement’ were very limited, and did not encompass all of the patients who may have experienced a benefit from t-PA.” Id. In Dr. Tikoo's view, “it is undeniable that there was a greater than fifty percent (50%) improvement in the patients who met the study's requirements for ‘improvement’ in clinical outcome after receiving t-PA, compared to those who did not.” Id. To buttress his opinion, Dr. Tikoo pointed out that the NINDS Study itself referred to a variety of measurements, including the Barthel Index and the Odds Ratio, and under both of these measurement standards, the extent of improvement exceeded fifty percent. Id. at 5–6. Finally, Dr. Tikoo pointed to a later double-blind, placebo controlled, randomized study—ECASS-III—that was published in 2008 in the New England Journal of Medicine that encompassed 110 European hospitals in 15 countries, involved 821 patients and “demonstrated that fifty-two percent (52%) of patients receiving t-PA reached a clinically favorable outcome.” Id. at 6–7.

3. Dr. Kaplan's Reply

In his Reply, Dr. Kaplan says that Dr. Tikoo's methodology is “patently flawed, unreliable, and outside the bounds of Federal Rule of Evidence 702” and must be excluded. Def. David Kaplan, M.D.'s Reply in Support of Defs.' Mot. in Limine To Exclude Test. of Ravi Tikoo, M.D. at 1 (Docket # 42) ( Def.'s Reply ). First, he says that since Dr. Tikoo acknowledged that the NINDS Study is the “gold standard,” “his attempt at reliance on more recent studies would be inapposite anyway.” Id. at 3. Dr. Kaplan asserts that the NINDS data “are crystal clear: 34% of patients have a favorable outcome from t-PA, when measured by National Institutes of Health Stroke Scale.” Id. “If a patient has a 34% chance of favorable outcome if given t-PA, it cannot be said that he more likely than not will have a favorable outcome if given t-PA.” Id. (emphasis in original).

Dr. Kaplan disparages Dr. Tikoo's “clums[y] attempts to distort” the NINDS Study. Id. Dr. Tikoo had noted that the increase from 21% (the percentage who recovered without t-PA) to 34% (the percentage who recovered with t-PA) is 13% and 13% is more than half of 21%. Id. Describing the calculation as “inapt,” Dr. Kaplan says it “does not even approach the legally required showing that the plaintiff himself had a greater than 50% chance of improved outcome had he been given t-PA.” Id. at 3–4 (emphasis in original). He goes on to say that even if the Odds Ratio is used, the “law does not require a showing that a t-PA patient is more likely than a placebo patient to avoid injury, the law requires that a t-PA patient is more likely than not to avoid injury.” Id. at 4 (emphasis in original). Similarly, Dr. Kaplan attacks Mr. Samaan's reference to ECASS–III as containing a recurring error of methodology, namely in asserting that its 52.4% figure is appropriate because it must be compared with 45.2% of the placebo group, who had a favorable outcome, an absolute increase of only 7.2%. Id. at 5.

II. DISCUSSIONA. The Maine Standard

In Phillips v. Eastern Maine Med. Center, 565 A.2d 306 (Me.1989), the Maine Supreme Judicial Court wrote that “to establish liability in a medical malpractice case, the plaintiff must show that the defendant's departure from a recognized standard of care was the proximate cause of the injury.” Id. at 307. Under Maine law, a person alleging harm from professional negligence has the burden to prove that it is more likely than not that the professional's negligence caused harm. Merriam v. Wanger, 2000 ME 159 ¶ 17, 757 A.2d 778, 782; Wetmore v. MacDonald, Page Schatz, Fletcher & Co., LLC, 476 F.3d 1, 4 (1st Cir.2007) (stating that “[i]n order for the negligent act to constitute proximate cause, the act or omission must be a substantial factor in bringing about the harm and the injury incurred must have been a reasonably foreseeable consequence”) (citation omitted).

B. Different Efficacy Based on Different Studies and Outcome Measures

Dr. Tikoo observes that the percentages Dr. Kaplan relies on from the NINDS Study reflect only one measure of potential favorable responses to t-PA treatment. The authors of the NINDS Study concluded that:

As compared with patients given placebo, patients treated with t-PA were at least 30 percent more likely to have minimal or no disability at three months, as measured by the outcome scales (absolute increase in favorable outcome, 11 to 13 percent).

NINDS Study at 6. Despite this 30% figure, Dr. Tikoo maintained that for Mr. Samaan, his chances for improvement with t-PA would have been more than 50%. First, Dr. Tikoo emphasized that the three month figures from the NINDS Study addressed the percentage of stroke victims who have “minimal or no disability” after three months. He characterized the NINDS Study as failing to address those individuals who obtain “a middle score or having some disability that's above baseline.” Dep. of Ravi Tikoo 24:15–19. In other words that 30% figure does not include patients who may have benefitted from t-PA but did not recover to the level of “minimal or no disability.”

Second, Dr. Tikoo...