July 30, 2010
CARY SCHWINN AND PAMELA SCHWINN, HIS WIFE, PLAINTIFFS-APPELLANTS,
WALL FAMILY MEDICAL CENTER, JOHN VITALI, M.D., MARY T. MITSKAVICH, M.D., COASTAL EAR, NOSE AND THROAT, DEFENDANTS-RESPONDENTS.
On appeal from Superior Court of New Jersey, Law Division, Monmouth County, Docket No. L-4648-04.
NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
Argued April 21, 2010
Before Judges Payne and Miniman.
Plaintiffs, Cary Schwinn and his wife, Pamela Schwinn,*fn1 appeal from an order of summary judgment dismissing their medical malpractice action against defendants John Vitale, M.D., an internist; Wall Family Medical Center, Dr. Vitale's practice group; Mary T. Mitskavich, M.D., an otolaryngologist or ear, nose and throat (ENT) specialist; and Coastal Ear, Nose and Throat, her practice group.
The record discloses that plaintiff Cary Schwinn suffered from sinusitis. After other treatments failed, on October 2, 2002, Dr. Vitale placed him on a course of tapering Prednisone and antibiotics, ultimately administering 420 milligrams of the corticosteroid Prednisone over six days along with a fourteen-day course of antibiotics, commencing on October 3. Following a CAT scan on October 4 that indicated both chronic and acute sinusitis, a retention cyst in the maxillary sinus, and a septal deviation to the left,*fn2 Dr. Vitale referred plaintiff to Dr. Mitskavich for further treatment by a specialist.
Dr. Mitskavich acknowledged the referral in a letter to Dr. Vitale, stating in that letter that she planned to administer an additional course of steroids and antibiotics, which she did, prescribing a tapering dose of 390 milligrams Prednisone over twelve days and the antibiotic Levaquin over twenty-one days,*fn3 along with saline irrigation, the decongestant Humabid, the nasal steroid spray Flonase, and the nasal decongestant spray Afrin. When plaintiff's condition did not improve, she performed surgery on December 5, 2002, preceding that surgery with an additional administration of 390 milligrams Prednisone to reduce swelling and operative bleeding. The surgery was successful.
Thereafter, plaintiff developed avascular osteonecrosis in his right hip, allegedly as the result of the administration of the steroids. He underwent bilateral hip replacements on November 10, 2003.
In a medical malpractice complaint filed on October 13, 2004, plaintiff set forth causes of action against defendants based on allegations of failure to warn of the consequences of utilizing steroids, failure to obtain plaintiff's informed consent, failure to provide alternative treatments, and failure to refer him to other physicians for consultations. The latter two causes of action were not pursued.
New York internist Perry Berg, M.D., was retained as plaintiff's expert. When his deposition was taken in 2007, Dr. Berg had been in practice for fifty-five years. At that time, he primarily treated geriatric patients, and he kept office hours two days a week. Dr. Berg had frequently served as an expert for both plaintiffs and defendants in New York, New Jersey and Connecticut. He was initially board certified in internal medicine in 1960 and was last board certified in 1977. He is not an ENT specialist, and he has never conducted ENT surgery. He has done no research in avascular necrosis and has not written on the subject. However, he treated two patients who developed avascular necrosis after a course of steroid treatment, the most recent being approximately fifteen years ago. In one case, the steroids were prescribed by a neurologist for an acute exacerbation of multiple sclerosis; in the other, the steroids were prescribed by a rheumatologist for the treatment either of lupus or rheumatoid arthritis. Dr. Berg agreed that both treatments were proper.
Dr. Berg issued two certificates of merit in this matter and an expert's report, dated April 18, 2006. In that report, Dr. Berg noted that as the result of treatment provided by Dr. Vitale and Dr. Mitskavich, plaintiff received 1200 milligrams of Prednisone between October 2 and December 4, 2002. The doctor commenced by noting that "avascular necrosis can be associated with short courses of steroids, in high doses."*fn4 He then stated:
I consider that [plaintiff's] treatment by both doctors was a breach of good medical care in that a modicum of communication and planning could have eliminated at least one and probably two of his courses of steroids without any decrease in the completeness of that care.
The doctor recognized that Dr. Mitskavich had testified in her deposition that, although she was unaware that plaintiff had been treated previously with steroids, even if that fact had been known she still would have instituted "maximum medical therapy" prior to considering surgery, consisting of Prednisone in tapering does, Levaquin, Flonase, Humibid, Afrin nasal spray, and saline nose drops. However, Dr. Berg concluded:
Once the treatment [instituted by Dr. Vitale on October 2] was begun, Dr. Mitskavich should have been made aware of it in the event that she wished to make changes to qualify it as maximal medical therapy. Once Dr. Mitskavich was aware that Mr. Schwinn had failed a course of treatment almost identical to what she was imposing, she could have prepared to do surgery when this failure was evident and when Mr. Schwinn had received a presurgical course of steroids, obviating another course of precisely what he had just taken. In the total absence of this simple communication and planning, Mr. Schwinn underwent three courses of toxic medication, never documented to clearly be of any value to him. It was a departure from the appropriate standard of care between Dr. Vitali and Dr. Mitskavich in their failure to communicate with each other concerning the course of treatment that had taken place. The continued use of steroids by Dr. Mitskavich exposed Mr. Schwinn to an unnecessary risk of an avascular necrosis and also was a departure from the standard of care. I find these to be lapses from good medical care and the proximate cause of Mr. Schwinn's avascular necrosis.
On August 7, 2007, Dr. Berg's deposition was taken. Dr. Berg testified that the incidence of the development of avascular necrosis following administration of steroids was so low that it need not be communicated to a patient as a risk factor. Plaintiff's attorney asked the doctor: "[W]as there a duty to warn Mr. Schwinn that [avascular necrosis] was a risk of the treatment that he was getting?" Dr. Berg responded:
I believe there is a duty to warn about steroid side effects. That specifically avascular necrosis would be what is mentioned is difficult for me to say. I believe that there has to be a conversation about the side effects of prednisone which run the gamut of diabetes, osteoporosis, infections and of osteonecrosis which is a subsection of the effect on bones.
I can't say specifically that the incidence of avascular necrosis is sufficiently high to make that part of the conversation, but I believe a conversation about steroid side effects has to take place and patient preference about the use of steroids has to at least be considered. Counsel for Dr. Vitale then followed up:
Q: Doctor, maybe I didn't understand your last answer, but I take it that you do not have the opinion that Dr. Vitali deviated from accepted standards of care by failing to tell Mr. Schwinn that he may get avascular necrosis when he was given the prednisone prescription on October 2nd? . . . .
A: He did not deviate when he failed to mention.
Counsel for Dr. Mitskavich obtained a similar admission:
Q: I understood your testimony to be similar to Dr. Mitskavich, that you said you could not give an opinion that they had a duty to warn of avascular necrosis. Correct?
A: Specifically about avascular necrosis, that's correct.
However, during the course of his deposition, Dr. Berg pursued the theory that he had introduced into the case in his expert's report that the lack of communication between Dr. Vitale and Dr. Mitskavich resulted in the failure of Dr. Vitale to inform Dr. Mitskavich that he was administering a course of steroid treatment to plaintiff at the time of the referral and eliminated Dr. Mitskavich's opportunity to modify that treatment so as to conform to her requirements as an ENT specialist for maximal medical therapy. According to Dr. Berg, if the communication had taken place, the cumulative dose of Prednisone administered to plaintiff could have been reduced to 780 milligrams (assuming that Dr. Vitale's 420-milligram dose was eliminated) or even further to 390, if the dose given as maximal medical therapy had also been utilized as the preoperative dose. The doctor acknowledged, as he had in his report, that Dr. Mitskavich had testified that, although she was unaware of the prior steroid administration, she would nonetheless have ordered a second course of steroid therapy. And he was unable to state, with a reasonable degree of medical probability, that Dr. Mitskavich would have prescribed less Prednisone if she knew of the prescription given by Dr. Vitale. He could state only that she "should" have done so. Further, the doctor was unable to testify that, in instances such as this in which the surgery did not occur until some time after the cessation of maximal medical therapy, that the administration of an additional course of steroids preoperatively was not beneficial in reducing polyposis, improving the visualization of the operative field, and decreasing bleeding.
Dr. Berg testified that it was his practice always to administer to his patients the smallest possible dose of steroids over the shortest period of time that would achieve the desired result, and he suggested that the failure of Dr. Vitale and Dr. Mitskavich to communicate resulted in the administration of a higher cumulative dose. He testified:
I think it's good medical practice, and I think that it is required by the standard of care that there be communication between people dealing with a patient, especially if there is the use of medications that ha[ve] certain dangers, and that's absolutely true with corticosteroids.
However, the doctor was unable to cite to any literature, authority or organization that supported his opinion that an internist is required to have some form of communication with a specialist each time a patient is referred. He stated:
No, I don't believe that I can recall any specific allusion to that. I think it is understood that's good medical practice - that that's good medical practice or the best medical practice.
Indeed, the doctor admitted that the practice that he espoused was "a personal preference. Yeah, I guess it's a personal preference."
In connection with Dr. Berg's position that the failure to communicate resulted in a deviation from generally accepted standards of care because it resulted in a higher than necessary cumulative dose, the following exchange occurred.
Q: Can you cite to me a textbook, an article, anything that says that a otolaryngologist treating a patient in combination with a primary care physician shall not give a patient 1200 milligrams of prednisone over a period of 63 days for [acute and chronic sinusitis].
A: No, I couldn't necessarily show you that.
Further, the doctor was unable to support his position that there was a dose dependent relationship between the use of corticosteroids and the development of avascular necrosis or that either doctor deviated from a recognized standard of care in prescribing as they did. In this regard, Dr. Berg offered four scientific articles, all written after the treatment to plaintiff had been rendered. However, upon questioning, the doctor admitted that one of the articles was wholly irrelevant; one did not provide guidelines as to the duration and dosage of steroids that would cause avascular necrosis or a standard of care for prescribing steroids; one suggested that a higher average dose is more important than a cumulative dose*fn5 in the development of avascular necrosis but also did not provide a standard of care for prescribing steroids; and the final article - a case history of one individual who developed avascular necrosis after a single dose of steroids - suggested "there was practically no dose of corticosteroids that can't cause avascular necrosis" but likewise did not set forth a standard of care for administration of the drugs. Significantly, Dr. Berg admitted, as well:
It is impossible to state at what point in the treatment of any patient that avascular necrosis was precipitated by that particular dose of prednisone, there is no question in my mind that he developed avascular necrosis as the result of the prescription of prednisone, but at what point in the actual 1200 milligrams that the d[i]e was cast is something I can't say.
The doctor testified additionally that the risk of contracting avascular necrosis as the result of the treatment protocols administered by Dr. Vitale and Dr. Mitskavich was "certainly less likely than more likely." He also admitted that some patients would contract avascular necrosis without any fault on their physician's part.
On February 18, 2009, Doctor Vitale moved for summary judgment, and on March 13, 2009, Dr Mitskavich filed a summary judgment motion, as well. Following oral argument, on May 8, 2009, the motion judge rendered an oral opinion granting the motions. The judge held, on the basis of Dr. Berg's testimony that neither doctor had a duty to warn plaintiff of the risk of avascular necrosis, that plaintiff's claims of failure to warn and lack of informed consent were not sustainable. The judge rejected plaintiff's argument that the doctors' conduct in prescribing 1200 milligrams of Prednisone increased the risk of harm to him because the claim was not set forth in plaintiff's complaint. Additionally, she held that Dr. Berg had failed to demonstrate a deviation from accepted standards of care by Dr. Mitskavich in ordering two courses of steroid therapy. Accordingly, she granted summary judgment to defendants. This appeal followed.
We concur with the motion judge's determination to grant summary judgment on plaintiff's claims of failure to warn and lack of informed consent. In reaching that conclusion, we are mindful of the standard of review applicable to the issue. See Brill v. Guardian Life Ins. Co. of Am., 142 N.J. 520, 540 (1995); see also Prudential Prop. & Cas. Ins. Co. v. Boylan, 307 N.J. Super. 162, 167 (App. Div.), certif. denied, 154 N.J. 608 (1998) (applying the Brill standard to appellate review). In short, we must determine "whether the competent evidential materials presented, when viewed in the light most favorable to the non-moving party, are sufficient to permit a rational factfinder to resolve the alleged disputed issue in favor of the non-moving party." Brill, supra, 142 N.J. at 540. "If there exists a single, unavoidable resolution of the alleged disputed issue of fact, that issue should be considered insufficient to constitute a 'genuine' issue of material fact for purposes of Rule 4:46-2." Ibid. (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250, 106 S.Ct. 2505, 2511, 91 L.Ed. 2d 202, 213 (1986).
Whether claims of failure to warn and lack of informed consent can be maintained is governed by standards first set forth in New Jersey in Largey v. Rothman, 110 N.J. 204, 211-15 (1988). In that case, the Supreme Court adopted the "prudent patient" or "materiality of risk" standard articulated initially in Canterbury v. Spence, 464 F.2d 772 (D.C. Cir.), cert. denied, 409 U.S. 1064, 93 S.Ct. 560, 34 L.Ed. 2d 518 (1972). In accordance with that standard, a duty on the part of a physician exists "to 'warn of the dangers lurking in the proposed treatment' and to 'impart information [that] the patient has every right to expect,' as well as a duty of 'reasonable disclosure of the choices with respect to proposed therapy and the dangers inherently and potentially involved.'" Largey, supra, 110 N.J. at 211 (quoting Canterbury, supra, 464 F.2d at 782). The scope of the duty is measured by the patient's need, and that need is the information material to the decision. Thus the test for determining whether a particular peril must be divulged is its materiality to the patient's decision: all risks potentially affecting the decision must be unmasked. And to safeguard the patient's interest in achieving his own determination on treatment, the law must itself set the standard for adequate disclosure. [Canterbury, supra, 464 F.2d at 786-87 (footnotes omitted).]
As noted by the Largey Court:
The breadth of the disclosure of the risks legally to be required is measured, under Canterbury, by a standard whose scope is "not subjective as to either the physician or the patient," id. at 787; rather, "it remains objective with due regard for the patient's informational needs and with suitable leeway for the physician's situation." Ibid. A risk would be deemed "material" when a reasonable patient, in what the physician knows or should know to be the patient's position, would be "likely to attach significance to the risk or cluster of risks" in deciding whether to forego the proposed therapy or to submit to it. Ibid. [Largey, supra, 110 N.J. at 211-12.]
As the Largey Court made clear, the prudent patient standard does not require disclosure of "every risk (not just material risks) to any patient (rather than the reasonable patient)." Id. at 213. The Court found:
The court in Canterbury did not presume to draw a "bright line separating the significant [risks] from the insignificant"; rather it resorted to a "rule of reason," [464 F.2d] at 788, concluding that "[w]henever non-disclosure of particular risk information is open to debate by reasonable-minded men, the issue is one for the finder of facts." Ibid.
In a holding that is significant to the present matter, the Largey Court then noted that disclosure of the risk in the case before it - the risk of lymphedema from an axillary node biopsy - was subject to debate, because the defendant argued the risk was remote and not material, whereas the plaintiff's experts disagreed, claiming that the plaintiff should have been informed of the risk. Largey, supra, 110 N.J. 213-14. Thus, the issue required resolution by a jury on retrial. Id. at 214.
Turning to the present matter, we note that in order for plaintiff to prove his case, plaintiff was required to show by expert testimony that avascular necrosis was a risk of which the defendant physicians should have been aware and that it was recognized within the medical community. Febus v. Barot, 260 N.J. Super. 322, 327 (App. Div. 1992). A dispute as to whether a risk was recognized raised the jury issue recognized in Largey. However, in the case before us that dispute does not exist. Alexander Chiu, M.D., Dr. Mitskavich's expert, stated in his report:
After a thorough search of the medical literature using a PubMed search engine, I did not find one case report detailing the incidence of avascular necrosis following the short term use of oral prednisone for chronic sinusitis. There are no documented guidelines for the use of steroids, nor is there a quoted incidence of avascular necrosis following prednisone use in the management of chronic sinusitis. In fact, the only literature quoting the incidence of avascular necrosis is in conjunction with long-term prednisone use (>4 months) in patients with leukemia or rheumatologic disease.
Robert L. Perkel, M.D., Dr. Vitali's expert found "no mention of a link between osteonecrosis and short-term corticosteroid use" in American medical literature, and only one research letter (not a peer-reviewed article) published in the Canadian Medical Association Journal that suggested an association between osteonecrosis of the femoral head and short-term oral corticosteroid use. Dr. Perkel was of the opinion that "the standard of care did not require Dr. Vitali to discuss osteonecrosis with Mr. Schwinn when he prescribed a short course of steroids."
As we have noted earlier in this opinion, Dr. Berg did not regard the risk of the development of avascular necrosis from the administration of corticosteroids by Dr. Vitale and Dr. Mitskavich to be sufficient to warrant a warning. As a consequence, there is no dispute in this case whether the disclosure of the risk of developing avascular necrosis was required, and summary judgment was therefore properly entered.
We are also satisfied that it was proper in this case to grant summary judgment on Dr. Berg's theory that Dr. Vitale and Dr. Mitskavich should have communicated regarding the treatment that was being given to plaintiff at the time of the referral and had been concluded by the time that plaintiff first saw Dr. Mitskavich. In that connection, the following exchange occurred during the course of Dr. Mitskavich's deposition:
Q: If you had known that Dr. Vitali had also given him a prescription for 20 milligrams of Prednisone, would that have altered your plan to give him the Prednisone?
A: No, it would not, because it's the combination of the anti-biotic with the steroid with the Flonase with the saline with the Humibid, with the Afrin that is his best shot at not having to have surgery.
As the result of this statement, plaintiff cannot establish a causal connection between Dr. Vitale's lack of communication and any injury to him. We note in this regard that any claim of lack of communication by Dr. Mitskavich cannot withstand summary judgment, because she in fact communicated to Dr. Vitale the details of the treatment that she proposed to prescribe.
Moreover, in this case, the existence or nonexistence of communication cannot be viewed in a vacuum.*fn6 As we have stated, it was Dr. Berg's position that, in any circumstance, a doctor must prescribe the lowest possible dose of steroids necessary to achieve a desired result. He postulated further that a lack of communication deprived Dr. Mitskavich of the opportunity to reduce the dosage that she administered, and that the administration of the additional steroids increased the risk*fn7 to plaintiff of contracting avascular necrosis. However, as we previously determined, Dr. Berg was unable to establish that Dr. Mitskavich violated any standard of care in administering, in conjunction with Dr. Vitale, 1200 milligrams of Prednisone over sixty-three days. Further, the doctor was unable to support his claim that there was a dose dependent relationship between the ingestion of Prednisone and the development of avascular necrosis. Indeed, Dr. Berg testified that it was impossible to state at what point in the treatment the necrotic condition was precipitated. Thus, Dr. Berg's opinion that Dr. Mitskavich violated a standard of care, and that her violation increased the risk to plaintiff of contracting avascular necrosis was nothing more than speculation. We have held in affirming the dismissal of a similar medical malpractice action in which plaintiff was able to establish inexperience on the part of an operating surgeon, but not any specific act of negligence, that "[m]ere guess or conjecture is not a substitute for legal proof." Pelose v. Green, 222 N.J. Super. 545, 551 (App. Div.) (citing Joseph v. Passaic Hosp. Ass'n. 26 N.J. 557, 575 (1958) and State v. Fritz, 105 N.J. 42, 64 (1987)), certif. denied, 111 N.J. 610 (1988). The Supreme Court has held in a case alleging dental malpractice:
The law does not make a dentist a guarantor that no harm or unfavorable consequence will arise from his treatment. The obligation assumed by him is to exercise in the treatment of his patient the degree of care, knowledge and skill ordinarily possessed and exercised in similar situations by the average member of the profession practicing in his field. Failure to have and to use such skill and care toward the patient as a proximate consequence of which injury results constitutes actionable negligence. A plaintiff who charges a deviation from such standard of skill or care must assume the burden of establishing facts showing not only the deviation but also a fact equally essential to recovery of damages, i.e., that the deviation was the reasonably probable cause of the injurious condition arising thereafter. [Germann v. Matriss, 55 N.J. 193, 208 (1970).]
In Germann, the plaintiff had established a deviation on the part of the dentist, but could not establish that the deviation was a proximate cause of her injury. Id. at 208-09. In the present matter, neither element has been demonstrated. As a result, summary judgment was properly granted.