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Pisano v. Ferrara

September 30, 2008

RONALD AND FRANCES PISANO, PLAINTIFFS-RESPONDENTS,
v.
ANTHONY FERRARA, D.M.D., DEFENDANT-APPELLANT.



On appeal from Superior Court of New Jersey, Law Division, Essex County, Docket No. L-4325-04.

Per curiam.

NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION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 ...


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