Opinion
DOCKET NO. A-5271-10T3
03-25-2013
ALISON ROSENBERG and HERBERT ROSENBERG, Plaintiffs-Appellants, v. MERCK SHARP & DOHME CORP., Defendant-Respondent.
Victoria J. Maniatis argued the cause for appellants (Sanders Vierner Grossman, attorneys; Ms. Maniatis, on the brief). Dino Sangiamo (Venable LLP) of the Maryland bar, admitted pro hac vice, argued the cause for the respondent (Hughes Hubbard & Reed LLP and Fox Rothschild LLP, attorneys; Eileen Oaks Muskett and David J. Heueck (Venable LLP) of the Maryland bar, admitted pro hac vice, of counsel and on the brief; Wilfred P. Coronato, on the brief).
NOT FOR PUBLICATION WITHOUT THE
APPROVAL OF THE APPELLATE DIVISION
Before Judges Fisher, Alvarez and St. John.
On appeal from the Superior Court of New Jersey, Law Division, Atlantic County, Docket No. L-3644-08.
Victoria J. Maniatis argued the cause for appellants (Sanders Vierner Grossman, attorneys; Ms. Maniatis, on the brief).
Dino Sangiamo (Venable LLP) of the Maryland bar, admitted pro hac vice, argued the cause for the respondent (Hughes Hubbard & Reed LLP and Fox Rothschild LLP, attorneys; Eileen Oaks Muskett and David J. Heueck (Venable LLP) of the Maryland bar, admitted pro hac vice, of counsel and on the brief; Wilfred P. Coronato, on the brief). PER CURIAM
Plaintiff Alison Rosenberg, and her husband, commenced this action alleging defendant Merck Sharp & Dohme Corp.'s drug Fosamax caused plaintiff to develop osteonecrosis of the jaw (ONJ) following a tooth extraction. The jury did not reach these claims because it found plaintiff did not suffer from ONJ.
On appeal, plaintiff contends the trial judge erred in excluding evidence of subsequent remedial measures -- a 2010 warning label -- which, she claims, hampered her attempt to impeach Merck's expert witness and caused an unjust jury verdict. Plaintiff also argues the trial judge erred in denying a motion to amend the complaint to conform to the evidence presented at trial. We find no merit in these arguments and affirm.
I
During the fifteen-day trial of this matter, the jury heard considerable evidence about plaintiff's alleged injuries and Merck's product. Because the issues raised in this appeal are informed by this evidence, we discuss the factual record at some length.
A
Between 1995 and 1997, the Federal Food and Drug Administration approved Fosamax for the prevention and treatment of osteoporosis in postmenopausal women. Fosamax, also known by the generic name alendronate, is taken orally and belongs to a class of drugs known as bisphosphonates.
From March 2001 until June 2006, plaintiff was prescribed and continuously took Merck's osteoporosis drug, Fosamax. On December 22, 2005, she underwent a tooth extraction; in this action, she contends her use of Fosamax caused the development of ONJ.
Osteoporosis was defined at trial as "a weakening of [the] skeleton" caused by the failure of bone-making cells (osteoblasts) to maintain pace with bone-resorbing cells (osteoclasts).
In late 2003, information began appearing in medical and scientific journals noting that ONJ had been seen in patients taking bisphosphonates. One article posited an association between ONJ and intravenous (IV) bisphosphonates. Between 2003 and early 2005, Merck received twenty-three reports of ONJ developing in Fosamax patients. No incidents of ONJ had been reported during the clinical trials for Fosamax, which involved 17,000 women, nor had any reports been received in the years between 1995 and 2003.
On May 6, 2004, the FDA received a request from a doctor to look into bisphosphonates and ONJ. The agency's report, which was finalized on August 25, 2004, found twelve cases of ONJ in alendronate patients and concluded that "it appears that [ONJ] may be a class effect," or risk, in bisphosphonates, and that there was "a continuing safety concern." Merck received the study on March 3, 2005.
By January 2005, Merck had internally decided to update the Fosamax patient information insert to include information about ONJ. In late January 2005, the FDA requested that, within six months, Merck add two paragraphs to the Fosamax package insert/label regarding ONJ. Merck presented a proposed label change to the FDA on March 1, 2005; the FDA responded with additional requested language on June 27, 2005, which Merck adopted in early July 2005. The approved language was implemented in the July 2005 label, within the six-month period originally required by the FDA.
The following language was added to the "Precautions" section of the Fosamax label in July 2005:
[ONJ], generally associated with tooth extraction and/or local infection, often with delayed healing, has been reported in patients taking bisphosphonates. Most reported cases of bisphosphonate-associated [ONJ] have been in cancer patients treated with intravenous bisphosphonates, but some have occurred in patients with post-menopausal osteoporosis. Known risk factors for [ONJ] include a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, cortico-steroids), poor oral hygiene, and co-morbid disorders (e.g., preexisting dental disease, anemia, coagulopathy, infection).Merck reiterated the warning in the "Adverse Reactions" section of the label, stating: "[l]ocalized [ONJ], generally associated with tooth extraction and/or local infection, often with delayed healing, has been reported rarely."
Patients who develop [ONJ] while on bisphosphonate therapy should receive care
by an oral surgeon. 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 for ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Once the label changes were implemented, sales representatives were told to provide physicians with the updated information and replace the labels on samples. Merck's website was similarly updated. Merck, however, did not send a letter directly to physicians informing them of the change. Suzanne Parisian, M.D., plaintiffs' expert in FDA regulations and compliance, testified she did not believe Merck did everything it could to spread awareness of the potential risk of ONJ, stating "[t]hey always could have done more."
In 2007, the American Society for Bone and Mineral Research (ASBMR) reported that although incidents of ONJ in patients taking bisphosphonates was consistent with a conclusion that an association existed between the two, "bisphosphonates ha[d] not been proven to be causal" in development of ONJ. Similarly, in a 2009 position paper by Salvatore L. Ruggiero, D.M.D., M.D., and others, the American Association of Oral and Maxillofacial Surgeons (AAOMS) noted that "[e]pidemiologic studies have established a compelling, albeit circumstantial, association between IV bisphosphonates and [ONJ]," but "the current level of evidence does not fully support a cause-and-effect relationship between [IV] bisphosphonate exposure and necrosis of the jaws." As for oral bisphosphonates, "[t]he causal association . . . is much more difficult to establish."
Dr. Ruggiero asserted that treatment and prevention recommendations were lacking, although a drug holiday, or break from taking bisphosphonates, was being considered. The 2007 ASBMR report had similarly noted that for patients, who had been receiving oral bisphosphonate therapy for more than three years, "some experts suggest stopping the bisphosphonate for a period before and after [an invasive dental] procedure." There was "no data," however, "to suggest stopping the bisphosphonate w[ould] improve dental outcomes," although it was unlikely any adverse effect would result in the skeletal system during that time.
B
Despite the lack of scientific evidence establishing a causal connection, Merck continued to warn of the potential risk, stating in its 2006 patient information guide for Fosamax that one possible side effect was "jaw-bone problems in some people [that] may include infection, and delayed healing after teeth are pulled." In 2010, Merck began including language regarding drug holidays in its Fosamax label, stating "[f]or patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ. Clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit/risk assessment."
In October 2005, plaintiff's OB/GYN, Debra Somers, M.D., who managed plaintiff's osteoporosis treatment, requested information from Merck regarding the possible connection between Fosamax and ONJ. On October 21, 2005, Dr. Somers received a written response that no reports of ONJ had resulted from any "controlled clinical trials." The letter noted, however, that "[l]ocalized [ONJ], generally associated with tooth extraction and/or local infection, often with delayed healing, has been reported rarely." The letter also included an extensive list of publications addressing the association between bisphosphonates and ONJ, including a copy of the "prescribing information" for Fosamax.
Dr. Somers claimed she was told ONJ "wasn't seen much in the oral bisphosphonates," and she never received labeling information suggesting Fosamax could cause ONJ. In her deposition, when asked whether she would have stopped plaintiff's Fosamax treatment had she known about ONJ, Dr. Somers replied she probably would not, since plaintiff was continuing to improve. Moreover, although Dr. Somers testified she would have warned plaintiff about ONJ in March 2005 if she had known, she saw plaintiff in January 2006 and continued to prescribe Fosamax until June 2006 and did so despite having admittedly learned in late 2005 of a possible connection between ONJ and Fosamax.
C
Plaintiff testified she had been on various pain medications since 1961, when an auto accident caused a serious back injury. Plaintiff had her first back surgery in 1966, and four more since, the last in 1998. Over the past forty years, plaintiff also received occasional steroid injections in her back, subject to her pain levels. During that time, plaintiff underwent a hysterectomy, carpal tunnel surgery, and a laproscopic hernia repair; in addition, she was diagnosed with thyroiditis, fibromyalgia, thoracic outlet syndrome, osteoarthritis in her knees, anemia, and temporomandibular joint syndrome (TMJ).
On March 31, 1998, Dr. Somers ordered plaintiff's first DEXA scan, a test which determines bone mineral density, providing a t-score which allows a physician to determine whether a patient has osteoporosis. A positive score to -1 is considered normal, while a score between -1 and -2.4 suggests the patient has "osteopenia," which is defined as "low bone mass," a condition that, unlike osteoporosis, is not considered to be a disease state. Scores of -2.5 and below indicate the patient is osteoporotic and, thus, "at increased risk of fracture."
In 1998, plaintiff's t-score was -2.38. A second scan in 1999 produced a score of -2.6; this was the first time she was diagnosed with osteoporosis. Dr. Somers prescribed Fosamax to be taken in daily ten milligram doses. Because the drug upset plaintiff's stomach, she ceased taking it.
In March 2001, plaintiff's t-score remained -2.6. Dr. Somers again prescribed Fosamax, then available in a weekly 70 milligram dose. By March 4, 2005, plaintiff's bone mineral density had improved to the point that she was osteopenic. Dr. Somers recommended that plaintiff continue taking Fosamax and testified she intended to prescribe it until plaintiff's t-score reached -1.5.
On December 22, 2005, in light of tooth pain unalleviated by a root canal, plaintiff's dentist, Dr. Abe Orlansky, referred her to Dr. Mark Funt, an oral and maxillofacial surgeon. Because the root canal failed, Dr. Funt decided to remove the second to the last molar on the right side of plaintiff's jaw.
On January 5, 2006, plaintiff returned to Dr. Funt, "complaining of pain with very sensitive gums, upper jaw, and lower jaw." Between December 22 and January 5, the packing had fallen out of the wound socket, which Dr. Funt admitted could allow for the introduction of bacteria to the wound. Plaintiff also had developed a bacterial kidney infection a few days earlier and was running a fever. Dr. Funt prescribed a steroid and antihistamine to help with inflammation. He acknowledged that steroids could delay wound healing and increase the risk of infection, and he explained that patients who undergo tooth extractions usually fully recover within two weeks. He saw plaintiff again on January 12 and 24, at which time no problems with delayed healing were observed.
In May 2006, plaintiff reported to Dr. Orlansky that she was in "intolerable" pain. The right side of her face, neck, ear, and eye were swollen and painful. Although she did not have pain at the extraction site, plaintiff felt her tongue was "getting stuck" on something below it. Dr. Orlansky confirmed "a piece of bone" was "cutting [her] tongue," and referred plaintiff to Dr. Funt for further evaluation.
When Dr. Funt examined plaintiff on May 16, he felt a "bony spicule" under plaintiff's gum on the lingual, or tongue, side of her jaw near the extraction site. He did not observe any infection. On May 24, Dr. Funt decided to "smooth the sharp bone down to make it more comfortable" and conducted an exploratory procedure with anesthesia, which required "mak[ing] an incision in the gum tissue, reflect[ing] the gum tissue back to expose the bone, and then tak[ing] a drill and just actually . . . drill[ing] the bone down so it is smooth." Once the bone was smooth, Dr. Funt re-covered it with gum tissue.
Testimony at trial defined "bony spicule" as "a small piece of bone that starts to work its way out through the gum tissue" and is usually sharp.
Dr. Funt saw plaintiff again on June 1, at which time he reported a small piece of visible bone. On June 8, a three millimeter piece of living bone was also exposed through the gum. Dr. Funt repeated the smoothing procedure. Dr. Funt explained that plaintiff should not "have bone come out near where a tooth was taken [out] six months [earlier]. That's just not normal." After plaintiff told him something she read about Fosamax and ONJ, he ordered further tests on her jaw. At the time, Dr. Funt believed plaintiff's symptoms were consistent with several possible diagnoses: (1) a bone infection called osteomyelitis; (2) osteoradionecrosis, which results from a disruption in the jaw's blood supply following radiation; or (3) elimination of bone secondary to an infection other than osteomyelitis.
On June 13, plaintiff again presented with pain and a small area of exposed bone, although her gum tissue was healing over. Regarding his prior possible diagnoses, Dr. Funt began "thinking more [ONJ] secondary to Fosamax." On June 19, Dr. Funt received the results of a CT scan on plaintiff's jaw, which revealed a normal jawbone and, in Dr. Funt's opinion, ruled out osteomyelitis. Dr. Funt also ruled out osteoradionecrosis because plaintiff had never received radiation treatment.
On July 6, Dr. Funt again noted the bone was healing over. Despite having ruled out osteomyelitis, he prescribed an antibiotic. Dr. Funt's August 1 records also reported that plaintiff had "continuous exposed bone on the lingual" side of her jaw, although it was "very small." He removed a loose piece of bone and sent it for a biopsy.
The pathology report revealed that the removed piece of "non-viable bone" was a "sequestrum." Unlike bony spicules, sequestra are "not attached to the main portion of the [jaw]bone." Although "[o]steonecrosis literally means dead bone," a sequestrum may be present in osteomyelitis, accompanied by infection in the surrounding tissue. The pathology report also noted evidence of "osteoclastic resorption" and "bacterial colonies."
Sequestra are pieces of dead bone rejected by the body and naturally eliminated.
Dr. Funt explained it also is not unusual to find bacterial colonies attached to bone removed from the mouth because bacteria are naturally present in the human mouth. In light of the pathology report and because he had "never seen anybody [who] had exposed bone for more than six to eight weeks," Dr. Funt decided that ONJ was "a much more viable diagnosis" than the alternatives.
E
Dr. Funt referred plaintiff to Dr. Thomas Sollecito, an oral medicine specialist. On August 15, 2006, Dr. Sollecito observed exposed bone, which he determined to be a sequestrum. Because plaintiff had used Fosamax for years and only recently stopped taking it, Dr. Sollecito believed it possible she had "bisphosphonate-related [ONJ]."
Dr. Sollecito admitted, however, that he also suspected plaintiff simply had a "post-extraction bony sequestration," understanding that sequestra can develop as a result of trauma, as well as in and around an extraction. Although sequestra occur in patients who have not taken bisphosphonates, Dr. Sollecito did not believe his two diagnostic theories were mutually exclusive. Believing it also possible plaintiff had osteomyelitis, Dr. Sollecito ordered a second CT scan. Because there was no additional destruction evident between the June and August scans, Dr. Sollecito ruled out osteomyelitis.
On August 22, Dr. Sollecito found a bony sequestrum and noted redness in the extraction area. He sent plaintiff to Dr. Funt on August 28 for a "gentle debridement" to remove the bone and smooth the area.
Dr. Sollecito's August 29 records reported "positive healing in right lingual mandibular plate" and "no exposed bone." Notwithstanding, plaintiff's pain level was severe. Although Dr. Sollecito believed it was possible plaintiff was suffering from low-grade osteomyelitis, he made a tentative diagnosis of ONJ "[b]ecause at this point in time . . . that appeared to [him] to be the most likely reason that she was exfoliating bone." Dr. Sollecito prescribed a second antibiotic and an antimicrobial mouth rinse, explaining that "[t]his particular cocktail of antibiotics . . . [had] been very effective in treating people with bisphosphonate-related [ONJ]."
Dr. Sollecito saw plaintiff for the last time on December 12, 2006, after she returned from a three-month vacation. She presented as completely healed. Dr. Sollecito conclusively determined plaintiff had been suffering from bisphosphonate-related ONJ as a result of the Fosamax, which he described as "a substantial factor in the cause" of her injury. Dr. Sollecito based his conclusion on the fact that plaintiff's condition improved once she began taking the antibiotics.
Dr. Sollecito testified that, in his practice, he had seen twelve cases of bisphosphonate-related ONJ, but plaintiff's case was the only one involving an oral bisphosphonate. Dr. Sollecito also acknowledged that he did not believe "a direct cause-and-effect" relationship had been shown between oral bisphosphonates and ONJ, although there were reported cases.
F
Merck's witness, Brent Ward, D.D.S., M.D., an expert in oral and maxillofacial surgery and ONJ, opined that plaintiff suffered from osteomyelitis, not ONJ. Although he did not examine plaintiff, Dr. Ward reviewed her medical records and concluded that the written records of Drs. Funt and Sollecito were inconsistent with a diagnosis of ONJ.
Dr. Ward explained that although there was a temporal association between ONJ and oral bisphosphonates, he did not believe a cause-and-effect relationship had been scientifically proven. In his own practice, he had seen more incidents of ONJ in individuals who had not taken bisphosphonates than in those who had. Dr. Ward noted that the biopsy evidence in ONJ patients showed that their osteoclasts were functioning, which is significant since Fosamax and other oral bisphosphonates are designed to inhibit osteoclasts.
Dr. Ward testified that a diagnosis of bisphosphonate-related ONJ required the presence of three characteristics: (1) "[c]urrent or previous treatment with a bisphosphonate"; (2) "exposed bone in the maxillofacial region that has persisted for more than eight weeks"; and (3) "no history of radiation therapy to the jaws." Moreover, the term "bisphosphonate-related ONJ" did not imply causation; it only meant "individuals have been reported to be on a bisphosphonate and have ONJ." With respect to plaintiff, Dr. Ward "believe[d] that the underlying cause of her jaw problems was related to infections and an infectious process that she was suffering from"; he did not "believe that Fosamax in any way contributed to what [she] was experiencing."
Dr. Ward pointed out that, at the time of her tooth extraction and subsequent jaw problems, plaintiff suffered from "a number of issues . . . associated with infection." Her medical history revealed that plaintiff was susceptible to infection, as demonstrated by prior problems with the same tooth. Prior to her referral to Dr. Funt, plaintiff presented to Dr. Orlansky with a pocket of infection on the tongue side of her tooth that was next to the bone and showed "evidence of advanced periodontal disease," which, Dr. Ward explained, could lead to osteomyelitis.
Dr. Ward believed that, in May 2006, plaintiff was suffering from a fistula, "a small opening of an infectious process." Alternatively, it could have been a post-extraction bony sequestrum, which Dr. Ward claimed was not uncommon following surgical extractions, even five months later. Moreover, roughness under the gum was not unusual following a surgical extraction and dry socket. He observed that Dr. Funt's records revealed that, on plaintiff's first visit, he neither felt nor saw exposed bone. Instead, Dr. Funt exposed the bone himself when he smoothed it on May 24. At that time, Dr. Funt's records demonstrated he saw "a normal healing extraction site" and living bone. Dr. Ward testified that procedures in that area can cause complications and trouble healing since it is "very thin tissue." Additionally, Dr. Ward testified that, "[i]n the smoothing process, . . . small pieces . . . come off," and the drilling process can "generate thermal or heat injury to the bone," and even bone death.
Having reviewed plaintiff's records, Dr. Ward concluded that plaintiff had exposed bone on June 1 and June 13 that was healing over. Neither Dr. Orlansky nor Dr. Funt noted seeing exposed bone on either June 21 or July 6, respectively. Dr. Ward stated it would not be unusual for the bone to have healed over between June 13 and June 21.
In Dr. Ward's opinion, the sequestrum that Dr. Funt found on August 1 "occur[red] as a result of infection." The subsequent pathology report showed evidence of osteoclastic resorption, which suggested the osteoclasts, which are targeted by oral bisphosphonates, were functioning in plaintiff's jaw. The report also showed evidence of infection and attempted healing. Dr. Ward explained that the pathology report supported his conclusion "because sequestrum are [sic] something that we see with infections of the jaw. . . . The bacteria and the infection can attack the jawbone itself and the blood supply of the bone. And so we see sequestr[a] as a result of infectious processes in the jaw."
Dr. Ward also referred to the fact that Dr. Funt's August 8 records made no notation of exposed bone. When plaintiff was examined by Dr. Sollecito on August 15, his preliminary diagnosis was osteomyelitis. And, on August 22, Dr. Sollecito's records did not disclose he saw exposed bone. Following the debridement on August 28 and the addition of a second antibiotic, plaintiff's symptoms resolved. Dr. Ward explained that the treatment plaintiff received was consistent with treatment given for osteomyelitis, and the events of May through September 2006 were consistent with infection.
Summarizing plaintiff's history, Dr. Ward explained that it began with "a documented infectious process" in December 2005. From May through September 2006, plaintiff suffered from difficulties in wound healing and continued infections. During 2005 and 2006, plaintiff was also using steroids, which can kill bone, cause difficulty in healing, and render the site more susceptible to infection. Moreover, in Dr. Ward's opinion, contrary to what Dr. Funt and Dr. Sollecito concluded, the CT scan could not rule out osteomyelitis since such scans "will miss a diagnosis of osteomyelitis one out of four times."
Dr. Ward testified that nothing in the sequence of events was consistent with ONJ. "There's no period of time in which she has exposed bone, exposed dead bone, that lasts over a period of eight weeks." Although Drs. Funt and Sollecito testified that plaintiff had exposed bone for longer than eight weeks, Dr. Ward asserted that their medical records contradicted their testimony, and he viewed the contemporaneous records were more reliable. Thus, Dr. Ward opined that "Fosamax was not a cause nor a substantial factor in the experiences that [plaintiff] had regarding her bone exposure," nor was it "a cause []or a substantial factor in dead bone in the jaw." In Dr. Ward's opinion, plaintiff suffered from osteomyelitis that was not caused by Fosamax.
II
At the end of her charge, the judge instructed the jury to determine: (1) whether plaintiff proved it was more likely than not that plaintiff had ONJ; (2) whether plaintiff's development of ONJ was a result of taking Fosamax; and (3) whether Merck negligently failed to adequately warn about the risks of ONJ from Fosamax. The jury returned a verdict, answering the first question in the negative, finding plaintiff did not suffer from ONJ. Pursuant to the judge's instructions, the jury ceased its deliberations and never reached the second and third questions or the questions posed about damages.
Judgment was entered in favor of Merck on March 3, 2011. Plaintiff unsuccessfully moved for a new trial and thereafter filed a timely appeal, arguing:
I. THIS COURT SHOULD REVERSE BECAUSE THE LOWER COURT ERRONEOUSLY EXCLUDED HIGHLY PROBATIVE IMPEACHMENT EVIDENCE AND THE ERROR CLEARLY LED TO AN UNJUST RESULT.We consider plaintiff's Points I, II and III collectively and, thereafter, Point IV.
II. THIS COURT SHOULD FOLLOW THE THIRD CIRCUIT AND A PRIOR NEW JERSEY RULING THAT OVERTURNED VERDICTS, ORDERING NEW TRIALS WHERE THE TRIAL COURT FAILED TO AFFORD PLAINTIFFS-APPELLANTS WITH THE ABILITY TO PROPERLY CROSS-EXAMINE DEFENDANT-[RESPON-DENT'S] STAR WITNESS IN EXCLUDING HIGHLY PROBATIVE IMPEACHMENT EVIDENCE.
III. MERCK'S EXPERT WITNESSES TESTIFIED CONTRA TO THE COMPANY'S OWN CORPORATE STANCES AND THE TRIAL COURT DISALLOWED THAT IMPORTANT FACT INTO EVIDENCE SO THE JURY NEVER LEARNED ABOUT THIS POWERFUL CROSS-EXAMINATION EVIDENCE.
IV. APPELLANTS ARGUE ALTERNATIVELY FOR A NEW TRIAL BASED ON THE LOWER COURT'S FAILURE TO ALLOW FOR THE PLEADINGS TO BE AMENDED REGARDING THE TRIAL EVIDENCE CAUSING THE JURY QUESTIONNAIRE TO BE TOO NARROW AND THE LACK OF THE ADJUDICATION ON THE MERITS OF ALL OF THE ISSUES BEFORE IT.
III
In her first three points, plaintiff contends she is entitled to a new trial because of the limitations the judge placed on the use at trial of Merck's 2010 Fosamax label. Clearly, the chief thrust of plaintiff's argument is her claim that the 2010 label constituted highly probative impeachment evidence that she believes was admissible for purposes of impeaching Dr. Ward's opinions. The danger, of course, was that the label had the potential to be viewed by the jury as evidence of culpable conduct or causation prohibited by N.J.R.E. 4 07.
We commence our consideration of this argument by first placing it in its proper context, which is to demonstrate its highly limited, if not nonexistent, probative value. That is, the jury found plaintiff did not suffer from ONJ; accordingly, the exclusion of the evidence was not capable of producing an unjust result if it was only admissible for the purpose or purposes of the issues the jury never reached. Viewed this way, plaintiff's argument must fail because the arguably relevant purpose for use of the 2010 label related to whether Fosamax caused plaintiff to develop ONJ and whether Merck adequately warned of this alleged tendency -- issues short-circuited by the jury's finding that plaintiff did not suffer from ONJ.
Moreover, even if a colorable argument could be presented about the admission of the 2010 label, its exclusion would still be required by N.J.R.E. 407, which declares, in part, that "[e]vidence of remedial measures taken after an event is not admissible to prove that the event was caused by negligence or culpable conduct."
N.J.R.E. 407, in practice, requires that a trial court consider the policy underlying the rule -- a "strong public policy encouraging prompt remedial measures," Szalontai v. Yazbo's Sports Cafe, 183 N.J. 386, 402 (2005), which would be hampered if a party's subsequent conduct could be used against it in a negligence action. See Dixon v. Jacobsen Mfg. Co., 270 N.J. Super. 569, 587 (App. Div.) (noting that the rule was "designed to encourage remedial measures to be taken in order to avoid the occurrence of similar accidents"), certif. denied, 136 N.J. 295 (1994). Federal decisions, which are of interest -- because N.J.R.E. 407 is based on its federal counterpart, see Brown v. Brown, 86 N.J. 565, 581-82 (1981) -- demonstrate that subsequent remedial measures cannot be admitted to prove culpable conduct or causation in the context of a case such as this. See, e.g., Werner v. Upjohn Co., 628 F.2d 848, 856, 858-59 (4th Cir. 1980) (recognizing that the rule "promotes an important policy of encouraging subsequent remedial measures[, which] to be effectuated [requires that courts] not be too quick to read new exceptions into the rule because by so doing there is a danger of subverting the policy underlying the rule"), cert. denied, 449 U.S. 1080, 101 S. Ct. 862, 66 L. Ed. 2d 804 (1981); Wusinich v. Aeroquip Corp., 843 F. Supp. 959, 962 (E.D. Pa. 1994) (holding that a "proffer [of] evidence of subsequent remedial measures in order to prove an element of the tort . . . would, in essence, permit the exception to swallow the rule"). Indeed, in a case quite similar, where defendant removed its product from the market, and where the plaintiff offered this subsequent remedial measure to show causation, the federal district judge determined that its admission "would certainly thwart the policy behind the rule." Wolf v. Procter & Gamble Co., 555 F. Supp. 613, 624 (D.N.J. 1982). We agree with this approach; the 2010 label could not be admitted to show causation or culpable conduct and, to the extent plaintiff sought to offer this evidence for that purpose, the trial judge properly excluded it.
Evidence of subsequent remedial measures, however, may be admitted for purposes other than proving culpable conduct or causation, as the final passage of N.J.R.E. 407 recognizes. Our courts have held that such evidence may be admitted to prove ownership or control, or to impeach a witness. See Brown, supra, 86 N.J. at 581; Lavin v. Fauci, 170 N.J. Super. 403, 407 (App. Div. 1979). Plaintiff argues the impeachment of Dr. Ward as fitting this exception.
We initially note that plaintiff was permitted to cross-examine Dr. Ward about the 2006 Fosamax patient information guide, which stated that "Fosamax may cause jaw-bone problems in some people," including "delayed healing after teeth are pulled." This was permitted even though this information did not impeach -- or at least not directly -- Dr. Ward's testimony because he did not testify inconsistently with that information. Dr. Ward stated that incidents of ONJ had been reported in persons taking Fosamax, and discontinuation of the drug "may" reduce the risk of development of ONJ; the word "may," also utilized in the 2006 Fosamax materials, Dr. Ward explained, does not "imply that scientific evidence exists."
Similarly, the relevant portion of the 2010 label did not admit a causal relationship between Fosamax and ONJ; instead, it stated that "for patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ." We agree Dr. Ward's testimony -- that there is "no evidence that discontinuation of the bisphosphonate for an extraction reduces the risk" of ONJ -- came perilously close to opening the door for plaintiff's use of the 2010 label, but his statement was made in connection with emergency extractions not covered by the language of the 2010 label. Also, as noted earlier, the jury determined that plaintiff did not suffer from ONJ; since the label focused only on the risk of ONJ from continuation of bisphosphonate when undergoing a tooth extraction, the exclusion of this evidence had no bearing on the jury's verdict.
However, if we assume a colorable argument could be made that the 2010 label contradicted Dr. Ward's testimony, the trial judge was entitled to restrain its use for impeachment purposes if a principled application of the N.J.R.E. 403 balancing test suggested its prejudicial effect or the potential for jury confusion. In this case, the record demonstrates that the label's limited probative impact on Dr. Ward's testimony was greatly outweighed by its prejudicial impact -- that it might be viewed by the jury as evidence of causation or Merck's alleged culpable conduct -- the very reason for which N.J.R.E. 407 exists.
See Petree v. Victor Fluid Power, Inc., 887 F.2d 34, 39 (3d Cir. 1989) (recognizing that the impeachment exception must not be used as a "subterfuge" to prove culpable conduct).
In the final analysis, in reviewing a trial judge's evidence ruling, we are "limited to examining the decision for abuse of discretion." Hisenaj v. Kuehner, 194 N.J. 6, 12 (2008). Substantial deference is accorded to evidentiary rulings. See New Century Fin. Servs. Inc. v. Dennegar, 394 N.J. Super. 595, 599 (App. Div. 2007); Benevenga v. Digregorio, 325 N.J. Super. 27, 32 (App. Div. 1999), certif. denied, 163 N.J. 79 (2000). A trial court's "relevance and admissibility determinations . . . will not [be] disturb[ed] absent a manifest denial of justice." Lancos v. Silverman, 400 N.J. Super. 258, 275 (App. Div.), certif. denied sub nom., Lydon v. Silverman, 196 N.J. 466 (2008). We find no abuse of discretion in the judge's rulings.
We also reject the argument that exclusion of the 2010 label unduly tied plaintiff's hands in cross-examining Dr. Ward. The judge permitted questioning regarding Merck's stance on discontinuation and allowed use of the 2006 materials. In addition, plaintiff had access to scientific documents like the AAOMS position paper for the same purpose. In this light, use of the 2010 label -- if limited to its only arguable purpose here, i.e., impeachment -- was cumulative. Green v. N.J. Mfrs. Ins. Co., 160 N.J. 480, 500-01 (1999).
IV
In her fourth point, plaintiff argues that the trial judge erred by denying her motion to amend the complaint, pursuant to Rule 4:9-2, to conform to evidence presented at trial as to the nature of her ailment. Such a ruling "is generally left to the sound discretion of the trial court," with which we will not intervene absent "a clear abuse of discretion." Franklin Med. Assoc. v. Newark Pub. Sch., 362 N.J. Super. 494, 506 (App. Div. 2003).
Here, plaintiff moved for an amendment at the close of the evidence, seeking to replace the word "osteonecrosis" with "osteonecrosis and/or jawbone problems." The judge correctly concluded, in denying relief, that changing the rules so late in the game was inappropriate and prejudicial. Specifically, the judge explained:
The ambiguity inherent in the phrase "and/or" was, perhaps, reason enough to deny the request, because Merck would not be able to understand what it was that it was asked to defend against, and the jury would not be able to understand what it was asked to decide. See, e.g., In re Massey, 317 N.J. Super. 302, 304-08 (Ch. Div. 1998). For present purposes, however, we will assume plaintiff meant to replace "osteonecrosis" with "osteonecrosis or jawbone problems, or both."
[W]hile the injury proofs might conform to a definition of other jaw problems, the causation problem[] proofs that [plaintiff has] presented and the defenses that [Merck has] presented have gone to the issue of ONJ. The warning itself, that argument is that [Merck] didn't warn of ONJ, not that they didn't warn of jawbone problems. And the sufficiency of the warning would be looked at totally different. Is it sufficient if they then say "jawbone problems"? They have attempted to say if we say "jawbone problems" then our wording is okay. The plaintiffs have, in the past, basically, seemed to have taken the position that [that] wouldn't be okay because you gotta tell them that you can get ONJ, death, death, death of the bone. Necrosis of the bone.
[Emphasis added]
Stated another way, the judge essentially determined that the proposed amendment did not conform to the evidence presented throughout the trial, which was that plaintiff had ONJ, caused by Fosamax, and that Merck negligently failed to warn of ONJ. As the judge recognized, to amend the complaint to allege that plaintiff had "jaw problems caused by Fosamax neither fits with what [plaintiffs'] causation experts . . . said, nor does it fit with what [their] warning experts . . . said."
Because the proposed amendment actually contradicted the arguments and evidence presented at trial, and entirely altered the foundation of plaintiff's case, the judge properly denied plaintiff's motion. In light of the significant potential for prejudice and the inconsistency between the proposed amendment and the proofs, the judge did not abuse her discretion in denying the motion.
Prejudice alone is a sufficient ground upon which to deny relief. Franklin Med. Assoc., supra, 362 N.J. Super. at 506.
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V
To the extent any other argument may be discerned from plaintiff's submissions on appeal, they are of insufficient merit to warrant further discussion in this opinion. R. 2:11-3(e)(1)(E).
Affirmed.
I hereby certify that the foregoing is a true copy of the original on file in my office.
CLERK OF THE APPELLATE DIVISION