Streimer v Biondo

[*1] Streimer v Biondo 2008 NY Slip Op 52164(U) [21 Misc 3d 1124(A)] Decided on October 21, 2008 Supreme Court, New York County Carey, J. Published by New York State Law Reporting Bureau pursuant to Judiciary Law § 431. This opinion is uncorrected and will not be published in the printed Official Reports.

Decided on October 21, 2008
Supreme Court, New York County

Ann Streimer, Plaintiff,

against

Ronald Biondo, M.D. and WILLIAM GRACE, M.D., Defendants.



108374/06



Appearances are as follow:

Plaintiff - Rosenberg, Minc, Falkoff & Wolff, LLP

Dr. Biondo - Catalano, Gallardo & Petropoulous

Dr. Grace - Costello, Shea & Gaffney, LLP

Joan B. Carey, J.

Plaintiff, Ann Streimer, began treating with defendant oncologist, Dr. William Grace, in or about 1997, at which time she had been suffering from breast cancer that had metastasized to her bones. In addition to the cancer, plaintiff was osteoporotic. Dr. Grace prescribed medications to plaintiff, which included bisphosphonates. It appears that for reasons relating to her medical insurance coverage, plaintiff ceased treating with Dr. Grace in late 1998, but later returned to his care in or about September of 2002. Plaintiff continued bisphosphonate therapy during the period when she did not treat with Dr. Grace and continued such therapy upon returning to his care. Dr. Grace initially treated plaintiff with a bisphosphonate known as Aredia, but switched to a bisphosphonate known as Zometa in early 2003. Both Aredia and Zometa are manufactured by Novartis.

In or about January of 2004, plaintiff began to complain to Dr. Grace about bony growths in her mouth, known in medical terms as osteomas. The osteomas became more severe over time, and, as a result, plaintiff decided to have an elective procedure to surgically remove them because, according to plaintiff's testimony, they made her uncomfortable, made it difficult for her to speak and "looked awful." On February 10, 2005, plaintiff consulted with defendant Dr. Ronald Biondo, who is an oral and maxillofacial [*2]surgeon, in connection with the removal of the osteomas.[FN1] Dr. Biondo was aware of plaintiff's medical history and that she was receiving intravenous bisphosphonates. On February 21, 2005, and again on April 5, 2005, Dr. Biondo performed osteoplasties to surgically remove the osteomas from plaintiff's jaw. It appears that such procedures were performed without complication. Thereafter, on May 5, 2005, Novartis issued a "Dear Doctor" letter directed to dental health practitioners, which advised that osteonecrosis of the jaw, which is bone damage or death resulting from poor blood supply, had been observed in cancer patients receiving treatment with intravenous bisphosphonate therapy, i.e., Aredia and Zometa, and that invasive dental procedures should be avoided. It is noted that a similar letter had previously been sent by Novarits to oncologists on November 24, 2004.

The "Dear Doctor" letter sent by Novarits to oncologists on November 24, 2004, states, in pertinent part, as follows:

"Novartis is fully committed to assuring timely dissemination of safety information about their products to the healthcare community. We are writing to inform you of changes made to the Precautions and Post-Marketing Experience sections of the Aredia (pamidronate disodium) Injection and Zometa (zoledronic acid) Injection prescribing information.

These changes relate to spontaneous reports of osteonecrosis of the jaw (ONJ), mainly in cancer patients, who have received bisphosphonates as a component of their therapy.

In the U.S. Package Insert for both Aredia and Zometa, the following information on osteonecrosis of the jaw has been added to the Precautions Section.

Precautions

Osteonecrosis of the jaw Osteonecrosis of the jaw (ONJ) has been reported in patients with cancer receiving treatment regimens including bisphosphinates. Many of these patients were also receiving chemotherapy and corticosteroids. The Majority of reported cases have been associated with dental procedures such as tooth extraction. Many had signs of local infection including osteomyelitis.A dental examination with appropriate preventive dentistry should be considered [*3]prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, corticosteroids, poor oral hygiene).While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based upon individual benefit/risk assessment.

In the U.S. Package Insert for both Aredia and Zometa, the following information on osteonecrosis of the jaw has been added to the Adverse Reactions section under Post-Marketing Experience.

Post-Marketing Experience Cases of osteonecrosis (primarily involving the jaws) have been reported in patients treated with bisphosphonates. The majority of reported cases are in cancer patients attendant to a dental procedure. Osteonecrosis of the jaw has multiple well documented risk factors including a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids) and co-morbid conditions (e.g., anemia, coagulopathies, infection, pre-existing oral disease). Although causality cannot be determined, it is prudent to avoid dental surgery as recovery may be prolonged. (See PRECAUTIONS)."

The "Dear Doctor" letter sent by Novarits to dental health practitioners on May 5, 2005, begins by stating:

"We are writing to inform you of an adverse event Osteonecrosis of the Jaw (ONJ) observed in cancer patients receiving treatment with intravenous bisphosphonates, Aredia and Zometa, which may have impact on the dental care of patients within your practice. While on treatment, invasive dental procedures should be avoided, if possible.

The prescribing information recommends that cancer patients:

receive dental examination prior to initiating therapy with intravenous bisphosphonates (Aredia and Zometa); and

avoid invasive dental procedures while receiving bisphosphonate treatment. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate [*4]the condition. Clinical judgment by the treating physician should guide the management plan of each patient based upon individual benefit risk assessment.

The May 5, 2005, "Dear Doctor" letter further states, similar to the letter that was previously sent to oncologists, that there were additions made to the Precautions Section of the U.S. Package Insert for both Aredia and Zometa, and sets forth those additions.It is noted that following her surgeries and issuance of the "Dear Doctor" letter to dental health practitioners, plaintiff was provided a copy of the letter by a periodontist named Dr. Kaner, on or about June 17, 2005. Immediately thereafter, according to plaintiff's deposition testimony, she went to visit Dr. Biondo to ask why he had not advised her about the letter. She testified that Dr. Biondo said he did not want to alarm her. According to Dr. Biondo's testimony, he explained to her that he wanted "to have more facts for her before discussing the letter at length."

Following plaintiff's February 21, 2005 and April 5, 2005 osteoplasties, she developed osteonecrosis of the jaw.[FN2] Thereafter, on June 16, 2006, with the filing of her summons and verified complaint, plaintiff commenced the instant action for medical malpractice and lack of informed consent against defendants. The crux of the plaintiff's complaint is that the defendants were negligent in failing to contraindicate the osteoplasties in light of her history of intravenous bisphosphonate therapy and in failing to adequately advise her of the risks of osteonecrosis of the jaw as a complication of the intravenous bisphosphonate therapy and the performance of the osteoplasties. Discovery has been completed in this action, the Note of Issue/Certificate of Readiness has been filed and this case is now ready for trial.

Defendants, respectively, move for summary judgment dismissing the complaint as asserted against them. "[T]he remedy of summary judgment is a drastic one, which should not be granted when there is any doubt as to the existence of a triable issue or where the issue is even arguable, since it serves to deprive a party of his day in court." Byrnes v. Scott, 175 AD2d 786 [1st Dept. 1991], quoting Gibson v. Am. Export, 125 AD2d 65 [1st Dept. 1987]. Initially, "the proponent of a summary judgment motion must make a prima facie showing of entitlement to judgment as a matter of law, tendering sufficient evidence to demonstrate the absence of any material issues of fact." Alvarez v. Prospect Hospital, 68 NY2d 320 [1986]; see also Winegrad v. New York Univ. Med. Center, 64 NY2d 851 [1985]; Zuckerman v. City of New York, 49 NY2d 557 [1980]. A failure by the movant in demonstrating, prima facie, its entitlement to judgment as a matter of law requires the [*5]denial of summary judgment, regardless of the sufficiency of the opposing papers. See Alvarez v. Prospect, supra; Winegrad v. New York Univ. Med. Center, supra. Where a prima facie showing of entitlement to judgment as a matter of law has been properly demonstrated, the burden then shifts to the party opposing the motion to produce evidence that establishes the existence of material issues of fact which require a trial in the action. See Alvarez v. Prospect, supra; Zuckerman v. City of New York, supra.

Dr. Ronald Biondo

Dr. Biondo seeks summary judgment dismissing the complaint as asserted against him, arguing that the he did not depart from the standard of care in performing the osteoplasties on plaintiff because the suspected association between intravenous bisphosphonates and osteonecrosis of the jaw was not generally known or accepted by the oral and maxillofacial surgery community at the time of the subject procedures. Dr. Biondo further argues that the"Dear Doctor" letters, as well as the package inserts, issued by Novartis, only warned against performing invasive dental procedures on patients receiving intravenous bisphosphonates, as opposed to stating that the performance of such procedures were contraindicated, and, thus, the performance of such procedures were not departures from the standard of care. With respect to plaintiff's claim against Dr. Biondo alleging lack of informed consent, it is argued that the information he provided to plaintiff with respect to the risks of the osteoplasties, as well as her option of not removing the osteomas, was sufficient for plaintiff to make an informed decision to consent to the procedures. Further, it is argued that because the risk of osteonecrosis of the jaw was not generally known or accepted by the oral and maxillofacial surgery community at the time of the subject procedures, it was not a reasonably foreseeable risk that should have been disclosed to plaintiff.

In support of his motion, Dr. Biondo relies upon, among other things, an affidavit in which he states his performance of the February 21, 2005 and April 5, 2005, osteoplasties was not a departure from good and accepted dental practice because such procedures were not contraindicated. According to Dr. Biondo, at the time such procedures were performed "the suspected association between intravenous bisphosphonates and osteonecrosis of the jaw was not generally known or generally accepted in the oral and maxillofacial surgeon community." Dr. Biondo added that "the information concerning the suspected association was limited to two (2) articles published in the Journal of Oral and Maxillofacial Surgeons which were based on retrospective case studies, and acknowledged that a cause and effect relationship had not been definitively established." Therefore, in his opinion, it was not a departure for him "to have been unaware of the suspected association between intravenous bisphosphonates and osteonecrosis of the jaw at the time . . . ." Dr. Biondo states in his affidavit that prior to performing these surgeries he never attended a lecture or read medical literature that identified a suspected link between intravenous bisphosphonates and osteonecrosis of the jaw, nor was he made aware of the "Dear Doctor" letter issued by Novartis to oncologists in September of 2004. Dr. Biondo further states in his affidavit that [*6]the"Dear Doctor" letters, as well as the package inserts, issued by Novartis, only warned against performing invasive dental procedures on patients receiving intravenous bisphosphonates, and "did not absolutely contraindicate" such procedures.

Additionally, Dr. Biondo states in his affidavit that he provided the plaintiff with sufficient information relating to the potential risks and the alternatives of the osteoplasties for her to make an informed decision with respect to consenting to the surgeries. Specifically, he disclosed the risk of poor wound healing and non-wound healing, as well as advising her that she had the option of not removing the osteomas. According to Dr. Biondo, "because the suspected association between osteonecrosis of the jaw and intravenous bisphosphonate therapy was not so widely recognized or widely accepted in the oral and maxillofacial surgery community, it was not a departure from good and accepted dental practice for [him] not [to] inform the plaintiff of the suspected association." During Dr. Biondo's deposition, he testified that he presented plaintiff with the risks of surgery, which included paresthesia (poor circulation), infection and nonhealing wounds, but did not have any discussion with plaintiff about the risk of such surgery while on bisphosphonate surgery. The consent forms signed by plaintiff in connection with the surgeries, which were annexed to Dr. Biondo's motion papers, appear to be standard surgical consent forms for oral and maxillofacial surgery containing standard language relating to risks.

The aforementioned affidavit of Dr. Biondo is sufficient to make a prima facie showing of entitlement to judgment as a matter of law, demonstrating the absence of any material issues of fact with respect to the adequacy of the dental treatment he provided to injured plaintiff, as well as the sufficiency of the information provided to her with respect to such treatment. See Suib v. Keller, 6 AD3d 805 [3rd Dept. 2004]; Juba v. Bachman, 255 AD2d 492 [2d Dept. 1998];see also Alvarez v. Prospect Hospital, supra. The burden, therefore, shifts to plaintiff to come forward with evidentiary proof in admissible form sufficient to establish the existence of material issues of fact which require a trial in the action. See Alvarez v. Prospect, supra; Zuckerman v. City of New York, supra.

In opposition to Dr. Biondo's motion, plaintiff relies on the sworn expert affidavit of an oral and maxillofacial surgeon. Plaintiff's expert sets forth that in his opinion, within a reasonable degree of dental certainty, Dr. Biondo departed from good and accepted medical practice in connection with the care rendered to plaintiff. The expert opines that "[i]t was a departure for defendant BIONDO to have agreed to perform the surgeries that he did on Ms. Streimer, in view of her age, her dental history and her use of intravenous bisphosphonates." Plaintiff's expert states that, prior to the alleged malpractice, there existed "professional literature detailing cases of patients developing osteonecrosis of the jaw after invasive dental procedures while on bisphosphonate therapy." The standard of care requires an oral and maxillofacial surgeon "be aware of the extant knowledge in the field, including all significant developments," and, therefore, according to plaintiff's expert, "it is not a valid excuse for defendant BIONDO to state that prior to performing the surgeries on Ms. Streimer in February and April of 2005, he had not read literature regarding the [*7]osteonecrosis link." Plaintiff's expert opines that Dr. Biondo should have been aware of the potential side effects of invasive dental procedures on patients receiving bisphosphonate therapy prior to receiving the "Dear Doctor" letter issued by Novartis to dental health practitioners, which was discussed in detail above.

Plaintiff's oral and maxillofacial surgery expert further sets forth that although the testimony indicates that Dr. Biondo may have discussed certain risks with plaintiff prior to the subject surgeries, she did not give a fully informed consent to these procedures because he did not inform her that she might develop osteonecrosis of the jaw as a result of the procedure. Plaintiff's expert sets forth that he disagrees with Dr. Biondo's opinion that he did not need to inform the plaintiff of the "suspected association" between osteonecrosis of the jaw, and intravenous bisphosphonate therapy because it was not so widely recognized or widely accepted in the oral and maxillofacial surgery community at the time of the surgeries, and states that such opinion is misguided. Lastly, with respect to causation, plaintiff's expert opined "that the performance by defendant BIONDO of invasive dental surgery on Ms. Streimer was the proximate cause of her osteonecrosis . . . ."

Based upon the conflicting expert affidavits submitted by the parties, it appears that issues of fact and credibility exist in connection with whether the treatment provided by Dr. Biondo deviated from good and accepted dental practice, and whether plaintiff was given sufficient information relating to the risks associated with such treatment to provide informed consent. Such issues cannot be resolved on this motion for summary judgment (see Bradley v. Soundview Healthcenter, 4 AD3d 194 [1st Dept. 2004]; Morris v Lenox Hill Hosp., 232 AD2d 184 [1996]). Furthermore. despite Dr. Biondo's argument to the contrary, the Court does not find the sworn affidavit of plaintiff's expert to be conclusory. Accordingly, Dr. Biondo's motion for summary judgment pursuant to CPLR §3212 is denied.

Dr. William Grace

Dr. Willaim Grace seeks summary judgment dismissing the complaint as asserted against him, arguing that the he did not depart from the standard of care with respect to the treatment he provided to plaintiff, and that nothing he did or did not do caused her any injury. With respect to plaintiff's claim against Dr. Grace alleging lack of informed consent, it is argued that Dr. Grace provided plaintiff with sufficient information regarding the benefits, risks and alternatives to bisphosphonate therapy.

In support of his motion, Dr. Grace relies upon, among other things, an affidavit in which he states "that bisphosphonates, were at the time [of the alleged malpractice], and remain today, the standard of care for a patient who is severely osteoporotic and suffering from metastatic breast cancer in bones." Dr. Grace sets forth that in January of 2004, plaintiff began complaining of bony growths in her mouth and that her complaints became more frequent and severe over the course of the year. There eventually reached a point where plaintiff insisted on having these bony growths removed. According to Dr. Grace, he observed these growths and had numerous discussions with plaintiff about them, discussing with her the potential that there was a relationship between the development of the growths and the bisphosphonate therapy she was undergoing. Dr. Grace further states [*8]that "[o]n virtually every occasion that we discussed this issue, we discussed, at length, the risks of ceasing bisphosphonate therapy versus the benefits of continuing their administration." He states that although there was no data demonstrating whether stopping the bisphosphanate therapy would be beneficial or harmful, he believed that this treatment appeared to be having an anti-cancer effect and that it did not seem productive to cease such therapy.[FN3] The alternatives to bisphosphonate therapy were also made known to plaintiff. According to Dr. Grace, in addition to the information that he provided to plaintiff about bisphosphonate therapy, she conducted her own research, and, in fact, provided him with copies of journal articles discussing the potential link between bisphosphonate therapy and osteonecrosis of the jaw.[FN4]

Additionally, Dr. Grace states in his affidavit that at no time prior to plaintiff undergoing her surgery was he made aware of an association between bisphosphonate therapy and osteonecrosis of the jaw in patients undergoing an invasive dental procedure, and, to this date, is unaware of any literature that establishes a cause and effect relationship between bisphosphonate therapy, invasive dental procedure and osteonecrosis of the jaw. Dr. Grace ultimately opines that he did not deviate from the standards of good and accepted medical care in his treatment of plaintiff, did not cause her any injury, and provided her with sufficient information to give informed consent to the treatment that he administered to her.

In opposition to Dr. Grace's motion, plaintiff relies on, among other things, the sworn expert affidavit of an oncologist. Plaintiff's oncology expert agrees with Dr. Grace in that bisphosphonate therapy was the standard of care for a patient who is severely osteoporotic and suffering from metastatic bone cancer. However, according to this expert, it was a departure for Dr. Grace not to have affirmatively warned plaintiff about the potential risk attached to invasive dental surgery while receiving bisphosphonate therapy. Plaintiff's oncology expert states that although Dr. Grace may have informed plaintiff about a possible [*9]link between bisphosphonate therapy and osteonecrosis of the jaw, he failed to inform her that the risk of osteonecrosis is significantly increased by undergoing invasive dental procedures, such as the osteoplasties. The expert sets forth that when Dr. Grace became aware that plaintiff was serious about having the osteomas removed,[FN5] he had a duty to inform her that as a patient receiving bisphosphonate therapy there was a possibility that such a procedure would cause her to develop osteonecrosis. According to plaintiff's oncology expert, if Dr. Grace carefully read the articles provided to him by the plaintiff herself, "he would have recognized that a discussion was imperative with regard to this patient's future dental treatment." Lastly, this expert states that the "Dear Doctor" letter issued by Novarits and sent to oncologists on November 24, 2004, put Dr. Grace on notice of the potential for patients receiving treatment with intravenous bisphosphonate therapy to develop osteonecrosis of the jaw after undergoing invasive dental procedures, and should have made him aware of this risk, which he needed to transmit to the plaintiff.

In addition to the sworn affidavit of the expert oncologist, plaintiff submitted the sworn expert affidavit of an oral and maxillofacial surgeon, which is discussed in detail above, in opposition to Dr. Grace's motion. It is noted that although the affidavit of the oral and maxillofacial surgery expert was submitted in opposition to Dr. Grace's motion, such affidavit does not address the treatment provided to plaintiff by Dr. Grace, and only addresses that treatment provided to plaintiff by Dr. Biondo. Notwithstanding, the expert oncologist opines that the performance of invasive dental surgery performed on plaintiff was the proximate cause of her osteonecrosis.

With respect to the medical malpractice cause of action as asserted against Dr. Grace, the affidavit which he submitted in support of his motion for summary judgment is sufficient to make a prima facie showing of entitlement to judgment as a matter of law, demonstrating the absence of any material issues of fact with respect to the adequacy of the medical treatment he provided to injured plaintiff. Specifically, as set forth by Dr. Grace, the use of bisphosphonates were the standard of care for a patient who is severely osteoporotic and suffering from metastatic breast cancer in bones. Additionally, as opined by Dr. Grace nothing he did, or did not do, in treating plaintiff caused her any injury. The burden, then shifted to plaintiff to come forward with evidentiary proof in admissible form sufficient to establish the existence of material issues of fact. Notwithstanding, plaintiff's own oncology expert stated in his affidavit that he agrees with Dr. Grace in that bisphosphonate therapy was the standard of care for a patient who is severely osteoporotic and suffering from metastatic bone cancer. It appears from the affidavit of plaintiff's expert, that he does not take issue with the treatment plan administered by Dr. Grace in connection with plaintiff's oncological care, but opines that Dr. Grace was negligent only in failing to properly advise plaintiff of the risks associated with such treatment plan, i.e., providing [*10]informed consent. Accordingly, Dr. Grace is entitled to summary judgment with respect to the medical malpractice cause of action as asserted against him.

With respect to the informed consent cause of action as asserted against Dr. Grace, although Dr. Grace states in his affidavit that he provided her with sufficient information to give informed consent to the treatment that he administered to her, plaintiff's oncology expert opines that Dr. Grace did not adequately advise plaintiff about the potential risk attached to invasive dental surgery while receiving bisphosphonate therapy. Further, the affidavit of plaintiff's oncology expert indicates that had plaintiff been properly advised that her chances of developing osteonecrosis of the jaw were significantly increased by undergoing the osteoplasties it would have been unreasonable to have elected to have had the surgery; and that rather than risking osteonecrosis of the jaw it would have been more prudent to simply live with the bony growths in her mouth. He expressly stated that it is "entirely possible that [plaintiff] would not have been willing to significantly increase the chances of developing osteonecrosis by undergoing the surgery for osteomas" [emphasis in original]. The opinion of plaintiff's expert, coupled with the fact that the evidence clearly demonstrates that plaintiff's dental health, specifically the possibility of developing osteonecrosis,[FN6] was a major concern of hers, creates triable issues of fact with respect to whether a reasonably prudent person in plaintiff's position would not have undergone the surgery for the osteomas if she had been fully informed. Furthermore, the expert oncologist opines that it was the performance of the invasive dental surgery, i.e., the osteoplasties, performed on plaintiff that was the proximate cause of her osteonecrosis. Based upon evidence submitted by plaintiff in opposition to that portion of Dr. Grace's motion for summary judgment dismissing the informed consent cause of action as asserted against him, the Court finds that material issues of fact exist, which warrant the denial of that portion of Dr. Grace's motion. See Alvarez v. Prospect, supra; Zuckerman v. City of New York, supra.

Lastly, it is noted that notwithstanding the denial of defendants' respective summary judgment motions, this Court, prior to the trial in this action, will conduct a Frye hearing to determine whether the opinions of plaintiff's experts relating to the link between bisphosphonates and osteonecrosis were generally accepted in the scientific community at the time of the performance of the dental surgeries at issue.

Based upon the foregoing, it is hereby [*11]

ORDERED that Ronald Biondo, D.D.S. s/h/a Ronald Biondo, M.D.'s motion for summary judgment dismissing the complaint as asserted against him is denied; and it is further

ORDERED that that portion of William Grace, M.D.'s motion for summary judgment dismissing the medical malpractice cause of action asserted against him is granted, and that portion seeking dismissal of the informed consent cause of action asserted against him is denied; and it is further

ORDERED that counsel for all parties are to appear before the court on November 3, 2008, at 9:30am, at 100 Centre Street, Room 1306, Part 40D, for jury selection.

Dated: 10/21/2008

J.S.C.

Check one: FINAL DISPOSITION NON- FINAL DISPOSITION

Check if appropriate: DO NOT POST REFERENCE

Footnotes

Footnote 1: It is noted that plaintiff had treated with Dr. Biondo prior to this date. Plaintiff presented to Dr. Biondo on December 10, 2002, with an area of exposed bone at tooth number 19, following a procedure performed by another surgeon. On December 27, 2002, Dr. Biondo performed an ostectomy at tooth number 19, which is the removal of non-viable aveolar bone, for the purpose of restoring vascular perfusion to the area to promote healing. According to the affidavit of Dr. Biondo, the ostectomy was successful and the area of exposed bone closed within two weeks.

Footnote 2: According to plaintiff's deposition testimony, as a result of her osteonecrosis of the jaw, she is unable to chew on anything hard and has to cut food in small pieces in order to eat. She testified that when eating, food not only gets caught between her teeth, but "gets up and under her bone," which requires her to irrigate her mouth. She sometimes experiences pain, and feels discomfort on occasion because her "teeth get very loose."Plaintiff also testified that as a result of the osteonecrosis she has suffered from tooth decay necessitating the placement of caps on two teeth. Moreover, she has been hospitalized three times in connection with infections to the affected area, which not only manifests itself within plaintiff's mouth, but causes her nose to redden and swell, and impacts her upper lip as well.

Footnote 3: At his deposition, Dr. Grace testified that he thought there would have been a risk in stopping the bisphosphonate therapy. According to Dr. Grace "when you have a winning formula, you're usually reluctant to change because bad things might happen if you did change."

Footnote 4: It appears that plaintiff became preoccupied with the notion that the medical issues relating to her mouth were connected with her use of bisphosphonates, and began conducting her own research on the subject. In and around June of 2004, plaintiff began providing Dr. Grace with copies of articles she had found dealing with the subject. These articles included Pamidronate and Zoledronate Induce a Vascualr Necrosis of the Jaw, A Growing Epidemic, Journal of Oral and Maxillofacial Surgery, Volume 61, September 2003; Osteonecrosis of the Jaw Associated With the Use of Bisphosphonates, a Review of 63 Cases, Journal of Oral and Maxillofacial Surgery, Volume 62, May 2004; and Ischemic Osteonecrosis Under Fixed Partial Denture Pontics, Radiographic Microscopic Features in 38 Patients With Chronic Pain, Journal of Prosthetic Dentistry, Volume 81, February 1999.

Footnote 5: It is undisputed that Dr. Grace was well aware that plaintiff intended to have the surgery at issue. Plaintiff testified at her deposition that she informed Dr. Grace that she decided to have surgery to remove the bony growths in her mouth before she saw Dr. Biondo in connection with the surgery. In fact, Dr. Grace discussed with plaintiff the risk of receiving chemotherapy at the time of the surgery and stopped her scheduled chemotherapy "to allow [the surgery] to go on unfettered."

Footnote 6: The evidence demonstrates that plaintiff continually discussed her dental health issues with her oncologist, Dr. Grace. Moreover, plaintiff conducted her own research with respect to the potential link between bisphosphonate therapy and osteonecrosis of the jaw, discussed this issue with Dr. Grace on several occasions, and provided Dr. Grace with copies of journal articles discussing the link between bisphosphonate therapy and osteonecrosis of the jaw.