September 30, 2008
RONALD AND FRANCES PISANO, PLAINTIFFS-RESPONDENTS,
ANTHONY FERRARA, D.M.D., DEFENDANT-APPELLANT.
On appeal from Superior Court of New Jersey, Law Division, Essex County, Docket No. L-4325-04.
NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
Argued September 10, 2008
Before Judges Parrillo, Lihotz and Messano.
In this dental malpractice action, defendant Anthony Ferrara, D.M.D., appeals from a December 19, 2006 order entering judgment in favor of plaintiff Ronald Pisano, after jury verdict, in the amount of $15,000 and from a June 15, 2007 order denying defendant's motion for judgment notwithstanding the verdict. We affirm.
This matter involves defendant's post-operative treatment of a Kent Vitek tempomandibular joint (TMJ) prosthesis (VK-1) that defendant implanted in plaintiff's left jaw during surgery in 1985 to repair facial injuries suffered by plaintiff while an on-duty Newark policeman. The actual surgery was uneventful, and the average life of the implant was approximately eight to twelve years.
The VK-1 was coated with proplast, a substance made of Teflon-carbon or Teflon-aluminum oxide fiber composite, which was later found to cause giant cell reactions, or tumors, in some patients. In fact, in 1990 and 1991, the Food and Drug Administration (FDA) issued advisories to the oral and maxillofacial surgery community warning that the implanted proplast was becoming a source of foreign body reaction. Although the FDA's first safety alert, issued on December 28, 1990, concerned a type of device (interpositional) other than the one implanted in plaintiff's jaw, both contained the same proplast that was the subject of the FDA warning, entitled "Serious Problems with Proplast--Coated TMJ Implant."
As one expert explained, the Teflon in the implant was breaking down, and the body was "forming Giant Cell granulomas or Giant Cell reactions to literally get rid of the proplast, but at the same time it was also causing damage to bone and the associated tissues around it." The damage could cause intense pain and limit joint function, or, conversely, occur while a patient remained asymptomatic. Consequently, the FDA recalled all such unused implants and recommended that symptomatic and asymptomatic "patients with these implants who have not had a radiograph taken in the past six months undergo immediate and appropriate radiographic examination," which would determine if the implant had lost integrity and if progressive bone degeneration had occurred. To this end, surgeons were urged to contact and re-examine patients with proplast implants and perform either a CT scan or MRI to detect the presence of giant cell reaction.
A second public health advisory was issued by the FDA in September 1991 that directly referenced plaintiff's VK-1 implant. The advisory warned all health care professionals and Vitek consignees that the implants distributed between 1973-1990 presented a "hazard to the health of patients" and reiterated the warnings in the 1990 safety alert. As to those patients with the implants who had not yet been notified of the potential for bone deterioration, the advisory recommended they be contacted as soon as possible. An MRI or CT scan should then be performed to detect any bone degeneration, and asymptomatic patients should thereafter be reviewed annually.
Despite these warnings, defendant did not contact plaintiff, and, in fact, did not see plaintiff after the 1985 surgery until June 1991 when plaintiff, after suffering a minor trauma to his jaw, presented with equilibrium problems and headaches that pre-dated the trauma. According to plaintiff, defendant never mentioned the 1990 FDA warning at the time. Although defendant insists he did, he had also indicated to plaintiff that the warning concerned another type of prosthesis. In any event, during the visit, defendant never performed diagnostic testing nor suggested implant extraction or annual monitoring.
Thereafter, defendant neither saw plaintiff nor communicated with plaintiff again until six years later, in December 1997, when plaintiff presented with the same symptoms as before-equilibrium, balance and headaches--but this time more exaggerated and frequent. Plaintiff also complained of ringing in his ears (tinnitus) and a "pins and needles" sensation in his jaw area. Despite these being recognized symptoms of potential giant cell reaction, defendant never mentioned either of the FDA warnings nor did he perform diagnostic testing or suggest extraction or annual monitoring.
There was also no disclosure by defendant when plaintiff presented two to four times in 1998 and again in September 1999 with continuing complaints. Plaintiff did not then see nor hear from defendant until December 2002 when, following an off-duty rear-end car accident, plaintiff presented with the same symptoms as before and was told by defendant that they were "part and parcel [of] the kind of surgery that [he] had."
Eventually, sometime in 2002 or early 2003, defendant informed plaintiff that his VK-1 implant had to be removed. For insurance reasons, plaintiff was referred to Dr. Peter Quinn, who performed the surgery in June 2003. During the operation, Dr. Quinn removed the VK-1 prosthesis as well as the giant cell reaction and all abnormal and inflamed surrounding tissue, grafted bone from plaintiff's lower jaw to create a new socket, and placed a new Lorenz prosthesis in it. In addition to the giant cell reaction, extensive damage to plaintiff's bone structure was revealed when Dr. Quinn removed the VK-1 implant including major bone loss on any surface touching proplast, loss of most of the fascia bone, erosion to the middle of the cranial fascia, and skeletonization of the mandible resulting in nerve exposure.
Post-operatively, in June and July 2003, plaintiff experienced pain in his jaw, for which he was prescribed narcotics, and numbness, but no infection. By December 2003, plaintiff no longer had pain, but the ringing in his ear, which pre-dated the latest operation, continued as did the numbness. During plaintiff's final visit in September 2005, he once again complained of pain in his jaw and jaw muscles, a popping sensation when he opened his jaw, and jaw muscle spasms.
Plaintiff sued for dental malpractice. At the ensuing trial, plaintiff proceeded under two theories of liability: deviation from the standard of care and lack of informed consent. As to the former, plaintiff's expert, Dr. Michael Ehrlichman, an oral and maxillofacial surgeon with thirty years experience, testified that the standard of care in the early 1990s relative to the preventive removal of the VK-1 implant was notification to the patient of the issues associated with the prosthesis and identified in the FDA literature at the time.
If, after receiving the proper advice, the patient chose not to have the implant removed, then the patient would be further advised to be followed clinically and radiographically. If, however, changes were then present, removal was recommended. In the case at hand, Dr. Ehrlichman opined to a reasonable degree of medical probability that, "[w]ith the symptoms that [plaintiff] had and the circumstances of the type of implant that was placed he should have been given notification[,] and early removal would have probably been recommended." Although Dr. Ehrlichman could not pinpoint exactly when the giant cell reaction first occurred, he considered plaintiff's symptoms consistent with a giant cell reaction.
On the issue of informed consent, plaintiff testified that, had he been given all of the information about his implant, such as its FDA recall, its shelf life of seven to ten years, that it already caused problems in some patients, and that people were having them removed because of giant cell tumors, "there's no doubt in [his] mind [he] would have had it removed." And finally, as to the injuries he claimed continued at time of trial, plaintiff still suffered from equilibrium and balance problems, ringing in his ears, and now a lack of sensation in the left side of his face, loss of ability to form words, and excessive spitting when speaking. These symptoms affect him emotionally as well, as he must constantly concentrate on forming words, fearful of inadvertently spitting, and must focus on balancing and keeping straight while walking.
Following close of testimony, summation and charge, the jury was given a revised verdict sheet, which contained separate questions on plaintiff's two theories of liability and read as follows:
1. Did the defendant, Dr. Ferrara deviate from the accepted standard of oral and maxillofacial surgery practice in his post operative care and treatment of the plaintiff?
If your answer is "Yes," proceed to Question 2.
If your answer is "No," proceed to Question 3.
2. Did the deviation of Dr. Ferrara from an accepted standard of oral and maxillofacial surgery practice substantially increase the risk of harm, if any, to the plaintiff?
If your answer is "Yes," proceed to Question 3.
If your answer is "No," proceed to Question 3.
3. Did Dr. Ferrara fail to disclose, during the course of his post operative care and treatment of the plaintiff, the material risks of all dental courses of treatment or non-treatment of the Vitek-1 implant?
If your answer is "Yes," proceed to Question 4.
If your answer is "No," and your answers to Questions 1 and 2 are "Yes," proceed to Question 5.
If your answer to 1, or 2 and 3 is "No" return your verdict for defendant, Ferrara.
4. Would a reasonably prudent person in the plaintiff's position, having been advised of the material risks of all dental courses of treatment, prior to Dr. Ferrara's recommendation for surgery of December of 2002, with the Vitek 1 implant, have consented to and undergone its removal?
If your answer is "Yes," proceed to Question 5.
If your answer to Questions 1, or 2 and 3, or 4 are "No," return a verdict for the defendant, Dr. Ferrara.
5. What amount of money would fairly and reasonably compensate the plaintiff for his harm, injury, pain, suffering and loss of enjoyment of life?
The jury returned a verdict for plaintiff, answering the verdict sheet interrogatories in the following manner: Question 1-Yes, 7-0 vote; Question 2-No, 6-1 vote; Question 3-Yes, 7-0 vote; Question 4-Yes, 7-0 vote; and Question 5-Yes, 6-1 vote, with a $15,000 award for plaintiff's "harm, injury, pain, suffering and loss of enjoyment of life[.]"
Plaintiff moved for a new trial on damages, or in the alternative, additur. Defendant cross-moved for judgment notwithstanding the verdict, claiming that questions three and four on the jury verdict sheet were duplicative and should not have been submitted since the jury's answers to questions one and two had already determined the issue of liability in defendant's favor. The trial judge denied both motions. As to the latter, the judge reasoned that there were two separate causes of action which merited separate questions, one for the deviation to provide appropriate post-operative care, treatment and follow up and the other for lack of informed consent regarding defendant's omission to inform plaintiff of the need for early removal of the prosthesis. As to the first, the judge noted that the jurors "concluded... that [the] failure of care and failure of follow up and treatment did not enhance the risk of harm[,]" and, as to the second, "the question of failure to disclose is a question of not deviation but the obligation of the physician to make options known to the reasonably prudent patient[,]" a question resolved by an objective analysis of what a reasonably prudent person would have done if he or she had been informed. The judge thus stated:
I find that the issue of negligence and deviation from acceptable standard of care, and the concept of a physician's obligation to provide the patient and allow a patient to make an appropriate judgment are certainly two concepts which are distinguishable and clearly can be distinguished under the facts in this particular case. And for these reasons [defendant's] Cross-Motion for judgment is... denied.
On appeal, defendant reiterates the argument that the judge erred by submitting jury interrogatories number three and four to the jury and further that there was no evidential basis for the damage award of $15,000. We perceive no merit in either contention.
Defendant essentially argues that deliberations should have ceased when the jury found his deviation from the standard of care was not the proximate cause of plaintiff's injuries. This argument, however, fails to appreciate the fact that the claims of deviation from the standard of care, see Gardner v. Pawliw, 150 N.J. 359 (1997), and lack of informed consent, see Largey v. Rothman, 110 N.J. 204 (1988), are not necessarily congruent. While there may be some overlap, they are distinct sub-groups of a broad claim of medical negligence, Baird v. Am. Med. Optics, 155 N.J. 54, 70 (1998); Perna v. Pirozzi, 92 N.J. 446 (1983); Teilhaber v. Greene, 320 N.J. Super. 453, 463 (App. Div. 1999), each with separate elements that comprise the cause of action. Thus, in order to establish a prima facie case of medical negligence based on deviation from the standard of care, "a plaintiff must present expert testimony establishing (1) the applicable standard of care; (2) a deviation from that standard of care; and (3) that the deviation proximately caused the injury." Teilhaber, supra, 320 N.J. Super. at 465 (citations omitted). On the other hand, a prima facie case of medical negligence based on lack of informed consent requires a plaintiff to show:
(1) the physician failed to comply with the applicable standard for disclosure; (2) the undisclosed risk occurred and harmed the plaintiff; (3) a reasonable person under the circumstances would not have consented and submitted to the operation or surgical procedure had he or she been so informed; and (4) the operation or surgical procedure was a proximate cause of plaintiff's injuries. [Ibid. (citations omitted).]
Unlike deviation from a standard of care, the theory of informed consent recognizes a separate duty, emphasizing the physician's obligation to inform, as well as treat, the patient. Matthies v. Mastromonaco, 160 N.J. 26, 39 (1999). The negligence lies in the physician's failure to disclose sufficient information for the patient to make an informed decision about the comparative risks of various treatment options. Perna, supra, 92 N.J. at 459; Skripek v. Bergamo, 200 N.J. Super. 620, 633 (App. Div.), certif. denied, 102 N.J. 303 (1985).
Providing a plaintiff's complaint fairly apprises the defendant of the claims to be raised at trial, there is no bar to asserting both types of medical negligence in the same trial. In Matthies, for instance, an elderly patient suffered permanent injury and confinement to a wheelchair when her treating doctor recommended bed rest instead of surgery for a hip injury. 160 N.J. at 30-32. At the trial of her medical malpractice claim, the plaintiff presented evidence that her physician deviated from the standard of care but was prevented from pursuing her informed consent claim. Id. at 29. Hence, the only issue submitted to the jury was whether Dr. Mastromonaco had breached a standard of care in selecting bed rest as a treatment alternative and failing to perform surgery on the plaintiff.
Id. at 33. The jury returned a verdict of no cause. Ibid. We reversed, 310 N.J. Super. 572, 599 (App. Div. 1998), holding the doctrine of informed consent applied as well, and the Supreme Court affirmed, holding that:
[b]ecause the patient has a right to be fully informed about medically reasonable courses of treatment, we are unpersuaded that a cause of action predicated on the physician's breach of a standard of care adequately protects the patient's right to be informed of treatment alternatives.
The issue of informed consent often intertwines with that of medical malpractice. Because of the interrelationship between the malpractice and informed consent issues in the present case, the jury should consider both issues at the retrial. [160 N.J. at 39-41 (internal citations omitted)].
In Teilhaber, a patient sued her orthopedic surgeon for medical negligence, alleging that he negligently attempted to treat her leg injuries with traction rather than surgery. 320 N.J. Super. at 456-59. The trial court granted the surgeon's motion to dismiss at the close of the plaintiff's case, reasoning that the claim was brought under the theory of deviation from the standard of care but was eventually presented on the basis of a lack of informed consent. We reversed, holding that even though the complaint omitted an informed consent claim, the judge should have permitted the plaintiff to amend her complaint to more specifically allege lack of informed consent, which would have allowed her to proceed on that basis as well. Id. at 466.
Here, of course, plaintiff's complaint fairly apprised defendant of the dual claims to be raised at trial. Indeed, paragraph twelve specifically alleges not only defendant's lack of post-operative care and treatment, but, as well, defendant's failure to notify plaintiff as to the potential need for removal:
12. During all times mentioned herein, it was the duty of... defendant Dr. Ferrara... to undertake the appropriate treatment, evaluations and operations of the plaintiff in a careful and prudent manner with the requisite professional skill care and judgment recognized as standards in the same profession under the then existing circumstances so that no harm would come to the plaintiff. Furthermore, it was the duty of th[is] defendant, once [he] became aware of problems associated with the Vitek Proplast Temporomandibular joint implants [he] placed in the body of the plaintiff [he] had the duty to immediately notify all of [his] patients of the FDA warning including the plaintiff, Ronald Pisano, to undertake immediate examination and evaluations of the plaintiff, offer him the opportunity of having the joint removed and arranging for annual MRI and CT scan examinations of the jaw of the plaintiff so that at the first sign of any giant cell tumor reaction to the implanted device and foreign body distribution to have it removed in a timely fashion so as to avoid extensive bone destruction and major joint and jaw replacement.
Though plaintiff's complaint may not have exactly "'spell[ed] out the legal theor[ies] upon which it is based[,]'" Teilhaber, supra, 320 N.J. Super. at 464 (quoting Farese v. McGarry, 237 N.J. Super. 385, 390 (App. Div. 1989)), they can clearly be inferred from its express language.
There being no bar to the assertion of these dual claims as not entirely congruent, neither was there any inconsistency in the jury's interrogatory answers. As noted, plaintiff's deviation claim was predicated on defendant's failure to order preemptive diagnostic testing (i.e., CT scans and MRIs) and/or properly monitor his condition as recommended in the 1990 FDA safety alert and 1991 FDA safety advisory, and/or recognize the symptoms of giant cell reaction exhibited by plaintiff before the eventual diagnosis in 2002. While the jury found defendant in fact deviated from the standard of care, it was also reasonable for them to have found that defendant's deviation was not the proximate cause of plaintiff's injuries, presumably because either plaintiff probably did not have a giant cell reaction at the time of the deviation, or, because of its microscopic nature, diagnostic testing would not have revealed the condition that did not fully manifest itself until 2002.
Plaintiff's informed consent claim, on the other hand, was based on defendant's failure to provide plaintiff the opportunity, through the presentation of information that a reasonable person under the circumstances would need, to make an informed consent decision about his care, namely whether to have the implant extracted at an earlier time. See Howard v. Univ. Med. & Dentistry of N.J., 172 N.J. 537, 548 (2002). As to the causative effect of the lack of informed consent, there is ample evidence to support the jury's finding that by foreclosing that option, plaintiff was harmed, because the device was allowed to fester in plaintiff's jaw causing, among other things, erosion of his cheekbone and damage to facial nerves and surrounding tissue.
Thus, the proofs at trial warranted submission of both claims to the jury. And given the distinctness of each, the jury's verdict is easily reconcilable. Simply put, the jury was free to decide that defendant's failure to order diagnostic testing did not increase the risk of harm to plaintiff, but that defendant's failure to disclose the option of implant removal damaged plaintiff, because a reasonably prudent person would have opted for such removal prior to 2002.
Defendant next argues that no damages should have been awarded because plaintiff did not sustain any injury from any delay in removing the implant. We reject this contention as wholly without merit. R. 2:11-3(e)(1)(B) & (E). Suffice it to say, there is ample evidence that plaintiff continues to suffer from ringing in his ears, headaches, balance problems, numbness, uncontrolled spitting and jaw muscle spasms, all symptoms of a giant cell reaction that had formed inside of plaintiff's jaw because of the VK-1 device that needed removal, causing erosion of the bone, nerve exposure and tissue damage.
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