Opinion
16214/96.
Decided January 10, 2005.
Defendants' Montefiore Medical Center, Dr. Joan Uehlinger and Dr. Ellen Friedman, jointly referred to as Montefiore, move for an order pursuant to CPLR § 3212 granting summary judgment dismissing plaintiff's complaint. Defendant New York Blood Center, Inc., (NYBC), by separate motion, also moves for an order granting summary judgment dismissing plaintiff's complaint.
Background
This action was brought on behalf of the decedent, Michael Boland to recover damages for the conscious pain and suffering sustained by the decedent and his wrongful death. The events which formed the basis for the claims asserted on behalf of the decedent, commenced when the decedent was referred by his primary care physician to Dr. Friedman on March 4, 1993 to determine the cause of his extremely high white blood count. Dr. Friedman diagnosed decedent's condition as myelogenous leukemia (CML). This medical condition is described as the malignant proliferation of white cells. The decedent remained under Dr. Friedman's care for approximately one year. During this period Dr. Friedman treated the plaintiff with interferon. Thereafter, the decedent decided to seek a bone marrow transplant at the National Institute of Health. After completing the transplant the decedent returned to Dr. Friedman's care but his condition had deteriorated. Dr. Friedman determined that the decedent needed a transfusion to raise his platelet count which had dropped below 20,000. The purpose of the transfusion, as testified to by Dr. Friedman, was to prevent spontaneous hemorrhage due to the low platelet count. Dr. Friedman ordered this procedure on March 16, 1995 and the transfusion took place in the Blood Bank at Montefiore Hospital on March 17, 1995.
Montefiore moving papers, Ex.K, Friedman EBT, pp. 18-20, 23
id, p. 24
id pp, 72-74
id p. 225
id, p. 225
Id p. 266
Defendant Dr. Uehlinger is the Director of the Blood Bank at Montefiore and responsible for treatment of patients in need of transfusions. Defendant Uehlinger testified at his examination before trial that he was present in the blood bank during the afternoon on March 17, 1995 when the decedent was brought to the Blood Bank for his final transfusion. The transfusion procedure commenced at 9:00 a.m. on March 17, 1995. The blood units were provided by defendant NYBC, who is described as, a regional blood center serving hospitals in the New York area. It is not disputed that the first two transfusions were completed without incident and that according to Uehlinger's testimony, within 15 or 30 minutes after he saw the decedent, Uehlinger was advised that the decedent began complaining of shortness of breath. Only a small amount of blood was transfused before the decedent experienced shortness of breath. The transfusion was stopped and shortly thereafter the decedent was transported by Dr. Uehlinger to the Emergency Department at Montefiore Medical Center. The hospital record (Blood Bank record) noted plaintiff's complaint occurring at 12:25 p.m. on March 17, 1995. At 12:30 p.m. the decedent was administered oxygen. The hospital record does not record that the decedent was in cardiac arrest at that time, but does record the administration of Benadryl and other medications to alleviate his complaint of shortness of breath. Intubation was performed in the Emergency Department at 12:50 p.m. Decedent's expert claims, inter alia that intubation occurred after a delay of 30 minutes which is not reflected in the record. Decedent expired at 1:47 p.m.
NYBC moving papers, Strewn Aff'd, Ex., A
Montefiore moving papers Ex., N, Uehlinger EBT, pp. 123-125
Montefiore moving papers, pp. 130, 143, 144, 147
Montefiore Reply Affirmation, Ex., H
id, Ex. F, Lynn Affirmation, Ex., H
id, Ex., J.
The autopsy report, prepared by the attending pathologist at Montefiore Medical Center on March 18, 1995 identified plaintiff's chronic medical condition as Myeloid Leukemia and noted his clinical diagnosis as "cardiopulmonary arrest due to non-cardeogenic pulmonary edema associated with transfusion reaction in a patient with thrombocytopenia and anemia as a consequence of chronic Myeloid Leukemia, . . . .". In addition, the pathologist determined the cause of death as Cardiopulmonary arrest "associated with transfusion reaction. . . ." Analysis of the donor's blood was performed which noted that the donor's platelets contained antibodies which adversely reacted to decedent's white blood cells.
id, Ex., G, Uehlinger Aff'd.
Plaintiff's verified complaint sets forth five causes of action. The first three causes of action; conscious pain and suffering, wrongful death and lack of informed consent are addressed to the Montefiore defendants. Two causes of action are directed against NYBC for negligent screening and testing of the units used in the transfusion performed at Montefiore and negligence, charging NYBC with failing to properly prepare the blood administered to decedent. Elements of A Malpractice Action:
Montefiore moving papers, Ex., C
The essential elements of a medical malpractice action are: "deviation or departure from accepted standards of practice" in the community; and that "such departure is a proximate cause of the injuries sustained."( See Bard, NY Medical Malpractice, § 1.1, p. 1-17 (1994); Barracca v. St. Francis Hospital 237 AD2d 396, 655 NYS2d 565; De Stefano v. Immerman 188 AD2d 448, 591 NYS2d 47). Here, plaintiff malpractice contentions all relate to alleged departures by Montefiore regarding what occurred after the last blood transfusion was administered to the decedent and with respect to NYBC, whether protective measures should have been employed to prevent the adverse reaction to the blood transfused.
In Keltnieks v. Brookhaven Mem. Assn. ( 53 AD2d 169, 176), the court identified the proof required in a malpractice action, stating:
"Clearly, on a trial of a medical malpractice action, as in any negligence action, a verdict finding liability can be sustained only if the proof adequately demonstrates that the negligence claimed (i.e. the 'departure') is the proximate cause 'of the Injuries sustained (see, Foley v. Gillick, 39 AD2d 546; Woods v. Pisillo, 35 AD2d 597; Peloro v. Abbondante, 35 AD2d 561; of Sherman v. Concourse Realty Corp., 47 AD2d 134)."
Also in Kimball v. Scors 59 AD2d 984, 399 NYS2d 350 and in Mortensen v. Memorial Hospital 105 AD2d 151, 483 NYS2d 264, 269 the Court held that the negligent act or omission must be a substantial factor in causing plaintiff's injury. Moreover, Judge Ciparick writing the majority opinion in Nestorowich v. Ricotta 97 NY2d 393, 740 NYS2d 668 articulated the duty of a physician:
"The prevailing standard of care governing the conduct of medical professionals has been a fixed part of our common law for more than a century ( see generally Pike v. Honsinger, 155 NY 201 [1898]). The Pike standard demands that a doctor exercise 'that reasonable degree of learning and skill that is ordinarily possessed by physicians and surgeons in the locality where [the doctor] practices' (id at 209). [FN3] Although malpractice jurisprudence has evolved to accommodate advances in medicine, the Pike standard remains the touchstone by which a doctor's conduct is measured and serves as the beginning point of any medical malpractice analysis."Discussion:
With respect to defendant Uehlinger's motion to dismiss, it is clear that his responsibilities regarding the treatment he provided to the decedent relates to events that followed the administration of the transfusions ordered by Dr. Friedman. No evidence is presented that Uehlinger should have or could have anticipated the allergic reaction that occurred when the last transfusion was administered. Plaintiff has not presented proof that Uehlinger had reason to believe that the blood units supplied by NYBC were not acceptable for use or would cause an adverse reaction.
Plaintiff's expert generically refers to "those employed at Montefiore" causing a delay in administering emergency treatment as a contributing cause of death. The deviation which plaintiff's expert is presumably referring to centers on contention that emergency personnel should have been called to the Blood Bank and in the alternative plaintiff's expert further opines that the decedent should have been intubated in the Blood Bank that would have averted a delay in administering emergency care to the decedent. This liability theory is based on pure speculation. Plaintiff's expert perhaps is charging Dr. Uehlinger with an error in judgment, but whatever plaintiff's expert may have intended to convey regarding Uehlinger's conduct, the record shows that an oxygen face mask was immediately applied to assist decedent's breathing which permitted the delivery of "100% oxygen into Mr. Boland's lungs" In addition, the hospital record amply identifies Benadryl, Solucortef and Einepkrine as medication administered in the Blood Bank in response to shortness of breath experienced by the decedent. More important, is plaintiff expert's tacit approval of the efforts made by Dr.Uehlinger, to remedy decedent's shortness of breath.
Plaintiff's opposing affd, Ex., T.
Montefiore, Reply Affirmation, Ex., F, Lynn aff'd
As to defendant Friedman, it is evident that he was not with the decedent during the transfusion and had no knowledge of the TRALI reaction. To the extent that plaintiff's expert places responsibility on NYBC for the transfusion related acute lung injury (TRALI) which allegedly caused decedent's demise, his opinion has no bearing on the treatment rendered by Friedman. Manifestly, Friedman did not participate in any of the medical decisions made by the physicians or personnel in the Emergency Department when resuscitation treatments were administered. None of the negligence theories alluded to by plaintiff's expert relate to Friedman. Moreover, plaintiff fails to connect the volume overload which supposedly overburdened plaintiff's "dilated heart", to Friedman without providing evidence that Friedman had prior knowledge or should have known that the blood units contained positive leukoagglutinating antibodies that would cause an adverse reaction.
In addition, plaintiff's expert does not challenge or suggest that Dr. Friedman's decision to order a transfusion was contraindicated. The affidavit submitted by one of Montefiore's experts, Dr. Richard Hirschman, supports Dr. Friedman's decision to order the transfusions to prevent the onset of spontaneous hemorrhages and Hirschman also states that an appropriate quantity was ordered. It is also noted that neither the New York State Department of Health nor the Food and Drug Administration make findings of negligence regarding the treatment rendered by Dr. Friedman and Dr. Uehlinger Summary Judgment:
Montefiore's moving papers, Ex., M, Hirschman Aff'd
id, Ex U.
The proponent of a motion for summary judgment carries the initial burden to tender sufficient evidence to demonstrate as a matter of law the absence of a material issue of fact. Alvarez v. Prospect Hospital, 68 NY2d 320, 508 NYS2d 923, 501 NE2d 320.) Once that initial burden has been satisfied, the burden shifts to the opponent, who must now go forward and produce sufficient evidence in admissible form to establish the existence of a triable issue of fact. The burden, however, always remains where it began, i.e., with the proponent of the issue. Thus "if the evidence on the issue is evenly balanced, the party that bears the burden must lose." Director, Office of Workers Compensation Programs v. Greenwich Collieries, 512 U.S. 267, 114 S.Ct. 2251, 129 L.Ed.2d 221 (1994); 300 East 34th Street Co. v. Habeeb, 248 AD2d 50, 683 NYS2d 175 [1st Dept. 1997].)
The role of the Court is to determine if bona fide issues of fact exist, and not to resolve issues of credibility. See Yaziciyan v. Blancato, 267 AD2d 152, 700 NYS2d 22 [1st Dept. 1999] Perez v. Bronx Park South Associates, 285 AD2d 402, 728 NYS2d 33 [1st Dept. 2001]; Glick Dullock v. Tri-Pac Export Corp., 22 NY2d 439, 441; Singh v. Kolcaj Realty Corp., 283 AD2d 350, 725 NYS2d 37 [1st Dept. 2001].)
Montefiore has met the initial burden of showing prima facie the absence of material issues of fact regarding the treatment rendered to the decedent and that such treatment was consistent with good and acceptable medical practice. Therefore, the burden shifted to the plaintiff to demonstrate the existence of material issues of fact warranting denial of Montefiore's motion.
Expert Testimony
It is well settled that the admissibility of expert testimony rests in the sound discretion of the trial court and such testimony is proper if it would help to clarify an issue requiring professional or technical knowledge beyond that of the jury. De Long v. County of Erie 60 NY2d 296, 457 NE2d 717, 469 NYS2d 611; People v. Cronin, 60 NY2d 430, 433, 470 NYS2d 110, 458 NE2d 351; Selkowitz v. County of Nassau, 45 NY2d 97, 101-102, 408 NYS2d 10, 379 NE2d 1140. Thus, unless the alleged act of malpractice falls within the competence of the jury to evaluate, the plaintiff must present expert testimony in support of the allegations to establish a prima facie case of malpractice. (See, Koehler v. Schwartz 48 NY2d 807; McDermott v. Manhattan Eye, Ear Throat Hospital 15 NY2d 20). Here in the case at bar, expert opinion evidence is mandated since the alleged acts of malpractice of Dr. Euhlwiger and Dr. Friedman are beyond the capacity of the jury to evaluate. Therefore, to ascertain whether the treatment rendered to the decedent was in keeping with acceptable medical standards the court is required to examine the accuracy and reliability of the opinion evidence offered to established malpractice.
An expert may not offer an opinion based on mere possibilities. ( Miller v. National Cabinet 8 NY2d 277.
The Court of Appeals has made it clear "that opinion evidence must be based on facts in the record or personally known to the witness. The expert in reaching his conclusion may not assume material facts that are not supported by evidence ( Cassano v. Hagstrom 5 NY2d 643, 159, NE2d 348, 646 187 NYS2d 1, rearg den 6 NY2d 882, Simo v. NY City Transit Authority, 2004 NY App. Div Lexis 15714 [Dec. 27, 2004]; Cappolla v. City of New York 302 AD2d 547, 755 NYS2d 100,; Law v. NY City Transit Authority 279 AD2d 325, 719 NYS2d 54, and where the opinion is based upon sources that are generally considered as sufficiently reliable or on facts supplied by a witness who is subject to cross examination, the experts opinion may be considered with all other relevant evidence by the jury. (see, Frye v. United States 293 F 1013; Hambsch v. New York City Transit Authority 63 NY2d 723, 725-726, 469 NE2d 516, 480 NYS2d 195).
In Frye, supra, the issue presented related to a novel theory proposed by defendant's expert concerning whether the results of a systolic blood pressure test can be influenced by emotional changes of the witness. The court rejecting the expert testimony noted "while courts will go a long way in admitting expert testimony deduced from a well recognized scientific principle or discovery, the thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular field in which it belongs." If the expert's opinion is based on a theory that is generally accepted in the scientific community, the Court of Appeals in People v. Wesley 83 NY2d 417, 633 NE2d 451, 611 NYS2d 97, held that such testimony may be admissible.
On the record presented, defendant Montefiore Medical Center's liability will turn on whether Dr. Uehlinger and Dr. Friedman are found to have deviated from good and acceptable medical practice. In this regard, although no issue is raised regarding the employment status of the physicians who treated the decedent, as a general rule, a hospital is not vicariously liable for the malpractice of a private physician who is not its employee ( Padula v. Bucalo, 266 AD2d 524, 698 NYS2d 911; cf Mduba v. Benedictive Hospital 52 NY2d 450, 384 NYS2d 880). Here, the court has treated the status of Drs. Uehlinger and Friedman as employees of Montefiore Medical Center.
Plaintiff's contentions regarding the liability of Montefiore are grounded on the opinion presented in the affidavit of plaintiff's expert who is board certified in internal medicine, oncology and hematology. As previously discussed, plaintiff's expert alleges that an "acute volume overload. . . ." was the negligence of both Uehlinger and Friedman. This alleged deviation is without support in the record.
The negligence conduct of the treating physicians at Montefiore offered by plaintiff's expert lacks information supporting the expert's opinion and fails to define the basis for the expert's opinion that the cause of death was volume overload. Plaintiff's expert attempts to explain this theory of liability, as a cause of death, by stating that decedent's heart was overburdened by the volume of blood that was transfused. This part of the opinion fails to state the basis for concluding: a) that a volume overload was administered to the decedent, or b) when the overload occurred, or c) whether it occurred during the first transfusion or the second transfusion or d) decedents demise occurred from the cumulative effect of all the transfusions. His opinion also does not refer to or discuss whether the volume overload occurred with the infusion of 30 cc's of platelets during the last transfusion or that volume overload [as the cause of death] is given general acceptance regarding patients who present with the same medical problems as the decedent. The foundation or basis of the expert's opinion was not presented in the expert's affidavit or in his report (see Davis v. Pimm 228 AD2d 885, 888 lv denied, 88 NY2d 815.)
The board certified Hematologist/Oncologist, Dr. Richard Hirschman's affidavit, submitted in support of defendant Montefiore's motion, spells out (as set forth in the transfusions records) that decedent's first two units that were transfused commencing at 9:10 a.m. and completed without incident or complaints by the decedent. The decedent began to experience shortness of breath during the early part of the last transfusion at approximately 12:20 or 12:25 p.m. on March 17, 1995. Both Hirschman and the autopsy report attribute shortness of breath to TRALI. caused by antibodies in the donor's blood. Finally, plaintiff expert's affirmation submitted in opposition to NYBC's motion to dismiss, contradicts the expert's opinion submitted in opposition to Montefiore's motion who asserted that the TRALI reaction was induced by the lieukoagglutinating antibodies in the donors plasma and not from an overload.
Plaintiff expert's remaining contentions regarding the delay caused by transporting the decedent to the emergency department and that diuretic therapy should have been started immediately are also without merit. Plaintiff fails to provide the bases for such opinions.
Plaintiff's causes of action leveled against NYBC are premised on the alleged failure of NYBC to screen and test the units of blood transfused to the decedent on March 17, 1995. In support of the allegations of negligence plaintiff submitted the affidavit of an expert who is board certified in "internal medicine, oncology and hemotology." At the outset plaintiff's expert presents the legal argument that NYBC had a duty to provide safe units of blood for distribution to hospitals that would be administered to patients. Thereafter, plaintiff expert's attempt to bolster this contention by affirming that the blood products used in the transfusion "should have been tested prior to their administration". The expert then opines that the blood products could have been easily tested to screen the blood for "offending antibodies."
Plaintiff's affirmation in opposition, Ex., 9
For reasons set forth, the opinion offered by plaintiff's expert do not controvert the showing made by NYBC that it was not negligent. NYBC's motion to dismiss is supported by, the affidavit Edwin Streum, the Director of Regulatory Affairs of NYBC, and the medical history of the donors of each blood unit that were screened showing test results. In addition, to providing the pleadings and the Supplemental Bill of Particulars addressed to NYBC's demand, the affidavit of Dr. Edward Eden, who is board certified in Internal Medicine, Pulmonary Medicine and Critical Care Medicine, the affidavit of Jay Brooks Jackson his background and training include his current position as professor and Director of Pathology at Johns Hopkins Hospital and University School of Medicine in Baltimore Maryland. Dr. Jackson's background includes his experience in directing diagnostic testing and viral screening of blood donors since 1985. Also included as exhibits are portions of correspondence from the National Institute of Health, a comprehensive summary regarding the treatment rendered to the decedent at the National Institute of Health, other records regarding the decedent, portions of the deposition transcript of both Dr. Friedman Dr. Uehlinger, a copy of the death certificate and the affidavit of merit dated September 11, 2002. NYBC's reply affidavit includes, attorney's affirmation, a copy of the transcript of the Blood Product Advisory Committee meeting that was held on June 15, 2001 and sponsored by the Department of Health, a copy of a report entitled "Transfusion Medicine Experts Struggle to Define TRALI," and reply affidavits of Dr. Jackson and Edwin Streum and the affidavit of Karen Shoos Lipton.
NYBC Reply Aff'd, Ex., N.
The affidavit submitted by Dr. Edward Eden, associate professor of clinical medicine at Columbia University College of Physicians and Surgeons, challenges plaintiff's expert that the quality of the "blood components which the decedent received on March 17, 1995 was a proximate cause of his death. Dr. Eden explains that TRALI is a pulmonary syndrome which occurred as a result of a unpredictable reaction to the last blood transfusion.
Dr. Jackson raises several arguments which are principally addressed to the viability of the opinion provided by plaintiff's expert. Here NYBC's expert states that pre-transfusion testing was not technically feasible in 1995. He also points to the fact that no regulations were issued by the Federal Drug Administration or the Departments of Health of New Jersey and New York requiring NYBC to engage in pre-transfusion testing. In Sorensen v. Taylor's Supermarket 304 AD2d 415, 757 NYS2d 438 [1st Dept. 2003] the court held the opinion rendered by plaintiff's expert was insufficient to raise a triable issue as to defendant's negligence where proof demonstrated compliance with all applicable statutes, rules, regulations. (see, also McKee v. Miles Lab., Inc. 675 F. Supp 1060, aff'd, 866 F 2d 219).
The departure, which plaintiff's expert asserts constituted negligence, relates to the NYBC's alleged failure to test the blood for the presence of antibodies before it was transfused. The issue resolution of this, rests on whether this opinion proffered by plaintiff's expert is competent evidence. At the outset it is clear that in a medical malpractice action the failure to offer competent medical expert testimony is fatal La Marque v. North Shore Univ. Hosp. 227 AD2d 594, 643 NYS2d 221 [2nd Dept. 1996]). In the case at bar, plaintiff had not provided this court with information concerning the applicable standards which NYBC failed to meet regarding the blood units administered to the decedent. In Hoemke v. New York Blood Center et al, 912 F 2d 550 [2d cir. 1990] the court granted summary judgment in favor of the defendant blood center since the standard of care at that time, did not require blood banks to screen out donors who carried the "blood borne disease" and the efficacy of the test used to discover tainted blood was found to be unreliable.
Here, nothing upon which plaintiff's expert based his opinion is contained in his affidavit, and in Romano v. Stanley 90 NY2d 444, 684 NE2d 19, 661 NYS2d 589, plaintiff brought a claim pursuant to the Dram Shop Act Charging the defendant with selling alcoholic beverages to a visibly intoxicated person. Expert testimony was offered to prove that the blood alcohol count of the driver established that she was visibly intoxicated. Judge Tutone reviewing the expert's opinion stated: "an expert affidavit proffered as the sole evidence to defeat summary judgment must contain sufficient allegations to demonstrate that the conclusions it contains are more than mere speculation and would if offered alone at trial, support a verdict in the proponent's favor". In the case at bar, NYBC's alleged malpractice is governed by the opinion proposed by plaintiff's expert which this court has concluded is not reliable.
Finally, NYBC presented as one of its exhibits the transcript of a hearing held on June 15, 2001 sponsored by the Department of Health and Human Services Food and Drug Administration, Center For Biologics Evaluation and Research. One of the issues presented at this hearing by the Blood Products Advisory Committee concerned whether the Federal Drug Administration should "consider" requiring testing of blood donors to identify who would be at risk of a TRALI reaction. After the committee reviewed the current data and disciplines from case reports which identified the following reactions of a recipient, as a leukoagglutimin reaction, pulmonary hypersensitive reaction, non-cardeogenic pulmonary edema, adult respiratory distress syndrome related to transfusion and allergic pulmonary edema, the committee determined that regulatory intervention should not be considered because existing technology is not available to perform routine granulocyte testing on every donor.
Consequently, both Montefiore and NYBC's motions are granted.
This constitutes the decision and order of the court.