June 23, 2010
JULIE RABINOWITZ AND DAVID RABINOWITZ, INDIVIDUALLY, AND AS GUARDIANS AD LITEM OF EMMA RABINOWITZ, A MINOR, PLAINTIFFS-APPELLANTS,
BERGEN OB/GYN ASSOCIATES; QUEST DIAGNOSTICS, INC.; MAYO MEDICAL LABORATORIES, A DIVISION WITHIN MAYO REFERENCE SERVICES, DEFENDANTS-RESPONDENTS, AND LISA MILLER, M.D., DEFENDANT.
On appeal from Superior Court of New Jersey, Law Division, Bergen County, No. L-2273-06.
NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
Argued January 20, 2010
Before Judges Wefing, Grall and Messano.
Plaintiffs appeal from trial court orders granting summary judgment to defendants Bergen Ob/Gyn Associates ("Bergen"), Quest Diagnostics, Inc. ("Quest"), and Mayo Medical Laboratories ("Mayo"). After reviewing the record in light of the contentions advanced on appeal, we reverse and remand for further proceedings.
Plaintiffs asserted claims of malpractice against these defendants after they learned that their daughter, born in May 2004, was afflicted with Tay-Sachs disease, a fatal neurological condition. Plaintiff Julie Rabinowitz first became pregnant in 2000 and received obstetrical care through Bergen. The first physician she saw at Bergen was Lisa Miller, M.D. Ms. Rabinowitz's 2000 pregnancy ended in a miscarriage. Dr. Miller had advised Ms. Rabinowitz that she was at risk for delivering a child with Tay-Sachs disease in light of her Ashkenazi Jewish ancestry. Dr. Miller recommended that she have a blood test performed to determine if she was, in fact, a carrier. A blood sample was drawn in February 2001, and Bergen forwarded it to Quest who forwarded it in turn to Mayo to conduct a serum hexosaminidase or "HexA" test.*fn1 The results were sent to Quest, which, in turn, returned its report to Bergen in March. The report stated in pertinent part:
The above results can be interpreted as NORMAL.
This means your patient is not a carrier (heterozygote) for Tay-Sachs (hexosaminidase A deficiency) disease by our method. We feel there is little risk of your patient having a baby affected by this disease....
The following statements are provided for your information. The above test results must be correlated with clinical findings to validate the usefulness of additional testing. Rare variants of hexosaminidase deficiency may not give results expected for Tay-Sachs disease. If a Tay-Sachs questionaire [sic] accompanies all samples submitted for carrier or homozygote detection, the possibility of missing these rare forms will be minimized. If the results are not clarified by the following [sic] comments, please contact Mayo Medical Laboratories directly.*fn2
In 2001 Ms. Rabinowitz became pregnant again and decided to seek obstetrical care from another physician. Based upon the report she received after her first pregnancy, she did not have a second HexA test. She was treated by Melissa Weinstein, M.D. and in January 2002 gave birth to a healthy boy. Ms. Rabinowitz became pregnant again and gave birth to a daughter in May 2004. When her daughter was eight months old, she was diagnosed with Tay-Sachs disease. Following that diagnosis, Ms. Rabinowitz came under the care of Robert Wallerstein, M.D., who arranged for another blood test, which, contrary to the first, showed that Ms. Rabinowitz was a carrier for Tay-Sachs disease. A test performed on her husband yielded similar results.
This litigation resulted. Plaintiffs originally named Dr. Miller, the original treating obstetrician, as an additional defendant. Dr. Miller was granted summary judgment in September 2008, and plaintiffs do not contest that on this appeal.
In the course of the litigation, plaintiffs served an expert report from Dr. Wallerstein in which he opined that there were three possible explanations for the difference in the test results: that the specimens used for the first testing had been mislabeled, that a technical error occurred during the testing or interpretive process, or the presence of a biochemical anomaly in Ms. Rabinowitz's blood which interfered with the testing process. Dr. Wallerstein said that if it were the result of mislabeling, it was not possible to identify at which juncture the mistake occurred.
In his report, Dr. Wallerstein explained the testing process used. The sample is first tested to determine the total hexosaminidase activity present in the sample and then the percentage of hexosaminidase A; this is repeated three times. The results reported for Mrs. Rabinowitz were 55%, 61% and 73%. According to the scale used by Mayo, 55% was considered indeterminate, 56%-80% considered normal and less than 50% abnormal. Dr. Wallerstein concluded that the determination that Ms. Rabinowitz was not a carrier for Tay-Sachs was appropriate based upon the test results reported.
He characterized as "unlikely" the possibility of a biological difference in Ms. Rabinowitz's blood sample that resulted in normal enzyme readings while she was, in fact, a carrier. He described the HexA test as "highly accurate with the majority of carriers being readily identified."
He concluded his report in the following manner:
In summary, Ms. Rabinowitz was mis-diagnosed as a non-carrier of Tay Sachs disease. The testing offered was appropriate. The interpretation of the result and actions taken were appropriate. The issue appears to be that the result did not reflect the true carrier status. In my opinion, this is most likely due to a misidentification/ handling error at some point in the process that cannot be identified with the records available. Alternatively, there remains a small possibility that there was a technical error in the laboratory at Mayo Medical Laboratories leading to the mis-diagnosis. Plaintiffs served an additional expert report, prepared by Richard L. Luciani, M.D. Dr. Luciani stated in his report that the initial negative test results reported at the time of Ms. Rabinowitz's first pregnancy, with subsequent positive testing, could not "occur without negligence on the part of either the physician's office where the initial blood was drawn or the laboratory processing of the sample." He listed three possibilities: mislabeling of the sample either at Bergen's office or Quest, Mayo testing the wrong sample and reporting those results as Ms. Rabinowitz's, and Mayo improperly conducting the testing. He noted, however, "It should also be appreciated that a biochemical anomaly of Ms. Rabinowitz' blood sample could also result in an improper test result. As subsequent screening revealed carrier status, this possibility is highly unlikely."
The three defendants all served responding expert reports. Mayo's expert was Hilary Vallance, M.D. Dr. Vallance explained that a false negative report could have occurred if Ms. Rabinowitz's blood carried HexB gene polymorphisms; these, she noted, can increase the percentage of HexA and thus mask carrier status. She considered it probable that Ms. Rabinowitz had this variant but had not seen the results of any testing for it.
Anthony C. Quartell, M.D., was the expert for Bergen. He found no evidence of malpractice on its part, stating, "Tay-Sachs testing, to the best of my knowledge, is highly accurate but not perfect." Quest's expert, Ronald A. Sacher, M.D., expressed the opinion that Quest handled Ms. Rabinowitz's sample according to the "standards of good laboratory practice."
Defendants moved for summary judgment, arguing that plaintiffs had failed to establish that it was more likely than not that fault on their respective parts was a proximate cause of Ms. Rabinowitz giving birth to a child afflicted with Tay-Sachs disease. Plaintiffs opposed these motions, arguing that in the factual complex presented, they were entitled to rely either on res ipsa loquitur or the burden-shifting paradigm employed in Anderson v. Somberg, 67 N.J. 291, cert. denied, 423 U.S. 929, 96 S.Ct. 279, 46 L.Ed. 2d 258 (1975). The trial court disagreed and granted defendants' motions. This appeal followed.
The scope of review of a trial court's grant of summary judgment is the same standard that the trial court uses in deciding the motion. Prudential Prop. & Cas. Ins. Co. v. Boylan, 307 N.J. Super. 162, 167 (App. Div.), certif. denied, 154 N.J. 608 (1998); Antheunisse v. Tiffany & Co., 229 N.J. Super. 399, 402 (App. Div. 1988), certif. denied, 115 N.J. 59 (1989). The appellate court first looks to whether there was a genuine issue of material fact; if there was not the appellate court then decides if the trial court's ruling on the law was correct. Ibid. Summary judgment should be granted "if the pleadings, depositions, answers to interrogatories and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact challenged...." R. 4:46-2(c).
An issue of material fact is genuine if considering the burden of persuasion and deciding all inferences in favor of the non-moving party, the issue would require submission to the fact-finder. Ibid. Bare conclusions from affidavits without factual support do not constitute outstanding questions of material fact. Brae Asset Fund, L.P. v. Newman, 327 N.J. Super. 129, 134 (App. Div. 1999). A factual issue cannot be created by an expert's net opinion alone. Smith v. Estate of Kelly, 343 N.J. Super. 480, 496-97 (App. Div. 2001). The expert opinion must contain evidential support, not just the witness's opinion on the matter. Kaplan v. Skoloff & Wolfe, P.C., 339 N.J. Super. 97, 103 (App. Div. 2001).
Plaintiffs make three contentions on appeal, that under res ipsa loquitur, "as extended by Anderson v. Somberg," defendants had the burden to exculpate themselves, that under the burden shifting alternative liability doctrine, summary judgment was improperly granted, and that the trial court should have granted an extension of the discovery period.
We have recently had occasion to summarize the principles underlying res ipsa loquitur.
To prevail on a claim of negligence, a plaintiff must establish that the defendant breached a duty of reasonable care, which constituted a proximate cause of the plaintiff's injuries. Ordinarily, negligence is a fact which must be proved and which will never be presumed.
The principle of res ipsa loquitur, however, creates an allowable inference of the defendant's want of due care, with respect to an injury-producing occurrence, upon a showing that (a) the occurrence itself ordinarily bespeaks negligence; (b) the instrumentality [causing the injury] was within the defendant's exclusive control; and (c) there is no indication in the circumstances that the injury was the result of the plaintiff's own voluntary act or neglect. The effect of the doctrine is to establish a prima facie case by permitting the jury to infer negligence. Res ipsa loquitur is not a theory of liability; rather, it is an evidentiary rule that governs the adequacy of evidence in some negligence cases.
The fact that there is no explanation for an accident does not, by itself, entitle a plaintiff to invoke res ipsa loquitur.
Rather, a plaintiff has the burden of producing evidence that reduces the likelihood of other causes so that the greater probability [of fault] lies at defendant's door.
Res ipsa loquitur is grounded in probability and the sound procedural policy of placing the duty of producing evidence on the party who has superior knowledge or opportunity for explanation of the causative circumstances. This foundational premise for res ipsa loquitur rests upon one of the doctrine's elements, that the instrumentality causing the injury was within the defendant's exclusive control. [Cockerline v. Menendez, 411 N.J. Super. 596, 611-12 (App. Div.), certif. denied, ___ N.J. ___ (2010) (alterations in original) (citations and internal quotation marks omitted).]
The trial court concluded that plaintiffs cannot at this juncture satisfy all of the elements of res ipsa loquitur. It noted, for instance, that Dr. Wallerstein's report is not sufficient to justify the conclusion that a false test result ordinarily bespeaks negligence. Dr. Wallerstein merely characterized as "unlikely" the possibility that the false negative reading was the result of a biological anomaly in Ms. Rabinowitz. This possibility was also recognized by plaintiffs' other expert, Dr. Luciani.
Plaintiffs, however, seek to analogize their situation to that which confronted the New Jersey Supreme Court in Anderson v. Somberg, supra.
The plaintiff in Anderson underwent a laminectomy, performed by defendant Somberg at defendant St. James Hospital.
67 N.J. at 294. During the course of the procedure, the tip of a surgical instrument broke off and could not be immediately retrieved from the plaintiff's spinal canal*fn3; the instrument was manufactured by the defendant Lawton Instrument Company and sold to the hospital by the defendant Reinhold-Schumann, Inc. Id. at 294-95. The plaintiff suffered serious injuries as a result of the fragment lodged in his spine and the need for additional surgery. Id. at 294. The Court noted that at the close of all the evidence, no theory for the cause of the rongeur's breaking was within reasonable contemplation save for the possible negligence of Dr. Somberg in using the instrument, or the possibility that the surgeon had been given a defective instrument, which defect would be attributable to a dereliction of duty by the manufacturer, the distributor, the hospital, or all of them. [Id. at 296.]
The jury nonetheless returned a no cause verdict as to each defendant. Id. at 297. The Supreme Court ruled that the plaintiff was entitled to a new trial.
[A]t the close of all the evidence, it was apparent that at least one of the defendants was liable for plaintiff's injury, because no alternative theory of liability was within reasonable contemplation. Since defendants had engaged in conduct which activated legal obligations by each of them to plaintiff, the jury should have been instructed that the failure of any defendant to prove his nonculpability would trigger liability; and further, that since at least one of the defendants could not sustain his burden of proof, at least one would be liable. [Id. at 298.]
Although the opinion of the Court in Anderson to which we have referred represented only the views of three members of the Court (a fourth concurred in the result but reached that point through a different analytical path), the Supreme Court has not adopted a different view. Indeed, it recently restated its adherence to these principles. Chin v. St. Barnabas Med. Ctr., 160 N.J. 454, 464-65 (1999) (noting "[o]ur support of this principle has been consistent and clear.") Plaintiffs urge that they stand in the same position as did the plaintiff Anderson and that, as a consequence, the burden of proof of exculpation shifted to defendants. The trial court did not agree. We have concluded that it is not possible to make a determination on that issue at this juncture.
To explain this conclusion, it is necessary to set forth in detail the history of the progression of discovery in this matter. We referred earlier to the two expert reports served by plaintiffs, that of Dr. Wallerstein and Dr. Luciani. Dr. Wallerstein is chief of the genetics service in the pediatric department at Hackensack University Medical Center. He is board-certified in genetic counseling, pediatrics, clinical genetics and clinical cytogenetics. We have referred to the substance of his report earlier in this opinion. Ms. Rabinowitz came under Dr. Wallerstein's care after her daughter was diagnosed with Tay-Sachs disease. Dr. Wallerstein was deposed after plaintiffs served his report. During that deposition, the following colloquy occurred.
Q: Doctor, would you agree that the serum hexosaminidase screening test has a sensitivity of less than 100 percent?
Q: When we talk about the sensitivity of a test, what does that mean to you?
A: It means the ability of the test to detect a carrier.
Q: So then a test with a sensitivity of less than a hundred percent is theoretically going to miss some carriers?
Q: All right. And that could happen even if the test is done perfectly, correct?
Q: Is the serum hex test a test that could miss carriers, even if the test is done perfectly?
A: In a very small percentage of cases, yes.
Q: Doctor, [plaintiff's counsel] identified the three potential causes of error that you have outlined in your report. Am I correct that the fourth potential explanation, as [defense counsel] pointed out, is the fact that the hex screening test is not 100 percent accurate?
A: I did not refer to that in my report, so I did not acknowledge that in the report. So if I answered the question before, I guess I did not understand the question, but yes, that should be acknowledged, that there is no medical test that is 100 percent.
Q: And am I correct that the fact that a subsequent test showed her to be a carrier doesn't rule out the possibility that the first result was erroneous due to the lack of sensitivity of that test?
A: When someone has a hexosaminidase A level, it is typically very consistent, so the two - the inconsistency between the tests suggests that the first test was in error. Now whether it was technical, as you proposed, within the acceptable technical error of the test, or just a human error in the way in which the test was performed, I cannot be certain; however, it seems unlikely that it is part of the technical aspect of the test.
Q: Okay. But it's not impossible that it's a result of the sensitivity of the test, just the inherent limitations of the test itself, correct?
A: That is a possibility.
Dr. Luciani was also deposed. He testified at his deposition that "[i]t's my understanding that if a patient is a carrier of Tay-Sachs, the specimen is handled correctly, and the test is run correctly by the laboratory and it's shown that they are in fact a carrier of Tay-Sachs, that it is almost impossible, maybe it is impossible for a prior test on the same blood to have been negative." Dr. Luciani indicated that if a different Tay-Sachs screen test was run the second time, then biologic anomaly could not be ruled out, although whether Mrs. Rabinowitz had a biologic anomaly could be resolved by simply testing her blood during discovery.
After hearing extensive oral argument on defendants' motions, the trial court determined they were entitled to summary judgment. The trial court concluded that the principles of res ipsa loquitur and Anderson, supra, were inapplicable in light of the fact that plaintiffs' experts conceded that the HexA test was not completely accurate.
Plaintiffs moved for reconsideration, including within their motion papers a supplemental certification from Dr. Wallerstein.
Dr. Wallerstein explained in his certification that lack of sensitivity of the test does not occur absent a biologic anomaly, which he ruled out:
Reference is made in my deposition that a screening test is not 100 percent sensitive. While I agree with that statement, the reason the screening tests are not 100 percent sensitive is because of the very fact that there may be either a biochemical anomaly or some form of error such as a mis-identification or a technical error in the laboratory. This is completely consistent with my opinions in this case. A mis-diagnosis can occur without negligence, but only because of the existence of a biochemical anomaly. Within a reasonable degree of medical certainty, Mrs. Rabinowitz did not have a biochemical anomaly. Therefore, the cause of the mis-diagnosis could only be either a mis-identification or a technical error in the laboratory.
The trial court denied plaintiffs' motion, finding it did not satisfy the criteria of Rule 4:49-2.
After defendants filed their summary judgment motions, but prior to the trial court hearing oral argument, Mayo's counsel served the expert report of Hilary Vallance, M.D., Director of the Biochemical Genetics Laboratory at the University of British Columbia. She noted that her research had shown that mutations to the HexB gene had the capacity to elevate the percentage of HexA and thus to mask one's carrier status for Tay-Sachs disease. She also reported that ten percent of individuals of Ashkenazi Jewish descent had these mutations and expressed the opinion that Ms. Rabinowitz likely shared these mutations, leading to the false negative result.
Dr. Vallance was deposed shortly after her report was served, and she restated this opinion. She explained that there were essentially two methods to test whether an individual was a carrier for Tay-Sachs disease, serum testing and leukocyte testing, and that there was a significant variation in the percentage of HexA reported between the two testing methods. Those individuals with the HexB gene mutations were reported to have a higher HexA percentage with serum testing than with leukocyte testing. Mayo used serum testing on the samples of Ms. Rabinowitz's blood that were delivered to it. She said that in her opinion, the false negative result was the result of Ms. Rabinowitz having a common HexB variant.
During the argument on defendants' motions, plaintiff's attorney argued that he needed more time to explore Dr. Vallance's opinions and to attempt to refute them. He thus sought an extension of discovery. The discovery deadline had passed, however, and the trial court declined to extend it in light of its conclusion that Anderson was inapplicable to this factual complex because Wallerstein had testified that the Tay-Sachs test is not 100% accurate, making it impossible to conclude that the false negative report "bespoke negligence" on the part of one or more of the defendants.
In the course of its opinion granting defendants' motions, the trial court held that plaintiffs had satisfied the first and third prongs of the Anderson test, that is, a blameless plaintiff, and the presence of all potentially culpable parties, but had not satisfied the second. It relied on language employed by the Supreme Court in Chin v. St. Barnabas Medical Center, supra, 160 N.J. at 466: "The basis of the Anderson principles is the certainty that one or more of the defendants participating in the events surrounding the accident was negligent." Wallerstein's testimony that the Tay-Sachs test was not 100% accurate made it impossible, according to the trial court, to be "certain" that one or more of defendants had been negligent.
In our judgment, the trial court ascribed too much weight to the Chin Court's use of the term "certainty." Few things, if any, are known with absolute certainty. Nothing else within the opinion indicates that the Court wished to impose a greater burden than that originally set forth in Anderson: that the particular event "bespeaks of negligence." The doctrine of res ipsa loquitur rests on probabilities, not certainties. Sanzari v. Rosenfeld, 34 N.J. 128, 140 (1961) (noting "Where, for example, a surgical sponge is left inside a patient after an operation, it is reasonable to say the probability is that someone has been negligent." (emphasis added)). See also Buckelew v. Grossbard, 87 N.J. 512, 526 (1981); Burnstein v. Metro. Bottling Co., 26 N.J. 263, 269 (1958). The test for whether an event "bespeaks of negligence" is whether it is generally accepted in the medical community that the injury, here, the false report, bespeaks negligence. The reports submitted by plaintiffs clearly met that threshold standard at this juncture of the matter.
Further, the report submitted by Vallance raised a completely new aspect that plaintiffs had not had the opportunity to explore fully. It is not entirely clear to what extent, if any, Wallerstein's opinions, ruling out a biochemical anomaly, conflict with the opinions of Vallance, who refers to polymorphisms, or genetic mutations, as the most likely cause of the false negative report. In his October 2008 deposition, Wallerstein was questioned in the following manner:
Q: Doctor, can you explain for me what polymorphisms are in relation to the genetic testing for Tay-Sachs disease?
A: Polymorphisms are changes in the genes that are not necessarily disease causing.
Q: How can that affect the screening test for Tay-Sachs disease?
A: I don't think that it really could.
A: Because if they're not disease causing, they would not lower the enzyme levels, and so it would not be significant for the carrier detection.
Q: Doctor, are there genetic mutations or polymorphisms, as we discussed, that would make it more likely for an individual to show a false negative on hexosaminidase serum testing?
A: I'm aware... of polymorphisms that cause you to look more like a carrier than you actually are in reality. I do not know of polymorphisms that make you have a higher activity level, which is why I responded before that the polymorphisms would really not apply in this case.
Vallance, on the other hand, testified in the following manner at her deposition:
A: That there is a discrepancy -- in people who carry this polymorphism there is a significant discrepancy between the percent HexA in white cells and the percent HexA in serum. That discrepancy can be up to 15%. You can have a percent HexA of 45% in leukocytes and it can be 60% in serum. That kind of discrepancy is highly unusual and we found it in all the cases. In all the carrier cases we could test who had the HexB variant, they all had this highly discrepant difference in percent HexA between the leukocyte and the serum.
Q: And I take it then that you are then concluding -- in your report you're coming to an opinion within a reasonable degree of medical probability that the false negative result is a result of her having a common HexB variant; is that your opinion?
A: That's my opinion.....
[M]y opinion is based on the general observation that carriers can be missed by the serum Hex screening method. And the specific observation in this case that the total Hex is at the very low end of the reference range and there is the variability in the percent HexA measurement which in my opinion increases the probability that she carried the HexB variant and thus, this is, in my opinion in all medical probability, the explanation for the false negative result.
At the time the summary judgment motions were argued and decided, there was no indication in the record whether plaintiff had been tested for the presence of this HexB variant, which would, according to Dr. Vallance's testimony, provide an explanation for her false negative test.
We recognize that the time for discovery had concluded. We also recognize, however, that this is an extremely complex matter, which required extensive investigation and preparation by the attorneys to even permit them to engage in meaningful discovery. It is also clear from the record that the attorneys had been diligent in pursuing discovery; plaintiffs' application for an extension of the discovery period was not occasioned by an attorney's lack of attention or dilatory conduct.
The trial court's denial of the requested extension, moreover, was not due to calendar restraints (neither an arbitration date nor a trial date had been scheduled) but, rather, to its view that further discovery was not necessary because the second element of the Anderson test was lacking. In our judgment, however, as we have noted, the trial court's view of this second element was too constricted. Plaintiff's attorney should have been given the opportunity to explore further the significance of the opinions offered by Dr. Vallance. Both of the studies she cited during her deposition, for example were published after plaintiff was first tested to determine if she was a Tay-Sachs carrier. That may bear upon whether it was generally accepted in the medical community at the time she had her first test whether a false negative report bespoke negligence.
The parties have not addressed before us whether this particular factual complex is sufficiently analogous to Anderson as to place the burden of exculpation upon defendants while not warranting an instruction to the jury that it must find at least one of the defendants negligent. We thus do not speculate upon that possibility. The attorneys are free to raise that question with the trial court if they can marshal authority for or against that proposition.
The order under review is reversed, and the matter is remanded for further proceedings consistent with this opinion.