SLAVO DOBROVIC, M.D. et al. v. STANLEY M. FRIEDMAN, M.D.

 

NOT FOR PUBLICATION WITHOUT THE

APPROVAL OF THE APPELLATE DIVISION

SUPERIOR COURT OF NEW JERSEY

APPELLATE DIVISION

DOCKET NO. A-4206-03T24206-03T2

SLAVO DOBROVIC, M.D. and

BOJANA DOBROVIC,

Plaintiffs-Appellants/

Cross-Respondents,

v.

STANLEY M. FRIEDMAN, M.D.,

Defendant-Respondent/

Cross-Appellant,

and

ELI LILLY and COMPANY,

Defendant-Respondent,

and

SHARAD WAGLE, M.D.,

JAVAD IQBAL, M.D.,

KENNETH A. CITAK, M.D.,

MORTEZA SHAHAMAT, M.D.,

and VALLEY HOSPITAL,

Defendants.

_____________________________________________________________

 

Argued March 8, 2006 - Decided August 16, 2006

Before Judges Wefing, Wecker and Graves.

On appeal from Superior Court of New Jersey,

Law Division, Bergen County, L-1222-01.

Appellant/cross-respondent Slavo Dobrovic

argued the cause pro se.

Lauren E. Handler argued the cause for

respondent Stanley Friedman, M.D. (Porzio,

Bromberg & Newman, attorneys; Ms. Handler,

of counsel; Ms. Handler, Borden R. Gillis,

and Darren T. DiBiasi, on the brief).

John Brenner argued the cause for respondent

Eli Lilly and Company (McCarter & English,

attorneys; John C. Garde and Debra M. Perry,

of counsel; Mr. Garde, Ms. Perry, and James H.

Knight, on the brief).

PER CURIAM

Plaintiff Slavo Dobrovic, M.D. and Bojana Dobrovic, his wife, appeal from a summary judgment order dismissing their products liability action against defendant Eli Lilly and Company (Lilly), and an order dismissing their medical malpractice action based on a jury verdict in favor of defendant Stanley Friedman, M.D. Plaintiff alleged in his complaint that Friedman negligently prescribed the antidepressant medication Prozac, manufactured by Lilly, and that Lilly failed to adequately warn of the alleged side effects of Prozac. We affirm.

Plaintiff, who was seventy-two years old at the time of trial, was born in Croatia, then part of the former Yugoslavia. While a seventeen-year-old student, plaintiff was arrested and imprisoned for approximately one year for writing "Free Croatia" on a city wall. After his release, plaintiff attended medical school. In 1970, plaintiff, his wife, and their children emigrated to the United States. Plaintiff completed his medical education in the United States, and in 1978, he opened a private practice with offices in Jersey City and Englewood. By 1982, plaintiff had become a board-certified orthopedic surgeon, and he was on staff at several hospitals, including Englewood Hospital.

On November 9, 1994, plaintiff admitted a patient to Englewood Hospital, but failed to attend to her for three days, explaining, "I just forgot her." Plaintiff also failed to "respond to multiple calls from nurses." On November 13, 1994, plaintiff examined the patient and backdated his progress notes, falsely indicating that he had treated the patient soon after her admission to the hospital. Nurses at the hospital reported plaintiff's conduct, and on December 13, 1994, Englewood suspended plaintiff's hospital privileges and instituted disciplinary proceedings against him. Plaintiff still had staff privileges at Meadowlands and Christ Hospitals, however, and he continued to see patients at his offices in Jersey City and Englewood.

In January 1995, plaintiff appeared before the Credentials Committee of Englewood Hospital for a hearing regarding the November 1994 incident. In a written report the committee expressed "considerable concern" that plaintiff's answers to their questions were "rambling and often inappropriate." The committee noted the possibility that "a neuropsychiatric problem may have caused or contributed to this situation." The committee therefore suspended plaintiff's hospital privileges and required that prior to reinstatement he undergo psychiatric, neurological, neuropsychological, and medical evaluations. The committee recommended that the hospital revoke plaintiff's staff privileges if he failed to comply. The Englewood Hospital Medical Executive Committee accepted the recommendations of the Credentials Committee, and plaintiff saw defendant Friedman, a board-certified psychiatrist, for psychiatric evaluation and treatment.

On February 1, 1995, plaintiff met with Friedman for the first time. During that session, plaintiff discussed his financial difficulties, revealing that his office properties were in foreclosure. He also discussed his family difficulties, explaining that his daughter had married a man he did not approve of, and that he feared for the safety of his daughter and son because they were both residing in Croatia. Plaintiff also indicated that he had recently lost approximately twenty-five pounds, had insomnia, had difficulty concentrating, was distracted, and felt compelled to wash his feet in cold water every evening, a routine he had had to follow while imprisoned in Croatia.

Friedman diagnosed plaintiff as suffering from a major depression, known as double depression superimposed on a chronic dysthymia, and obsessive compulsive disorder. He also determined that plaintiff was chronically angry and unhappy, but did not suffer from bipolar disorder, a psychiatric condition characterized by alternating periods of depression and mania. Friedman concluded that plaintiff "was not psychologically oriented and . . . would not benefit from psychotherapy alone." Thus, in addition to weekly therapy sessions, Friedman decided to treat plaintiff with antidepressant medication and prescribed a "basic dose" of 20 mg of Prozac per day. Friedman acknowledged during his deposition that he did not discuss with plaintiff the potential side effects of taking Prozac during the initial session on February 1, 1995.

On February 5, 1995, plaintiff's wife, Bojana, who handled the couple's finances, returned to Croatia to resolve several developing financial problems, including problems concerning their purchase of shares in a hotel from the Croatian government. Bojana had made a similar trip in November and December 1994, and when plaintiff opened the mail in her absence, he was surprised to discover that their monthly expenses were $20,000 to $30,000. When Bojana returned home on February 19, 1995, she discovered that plaintiff was unusually anxious, very talkative, and sweaty, and plaintiff experienced sexual dysfunction during their marital relations. Bojana said she called Friedman to discuss these symptoms, but he refused to talk to her.

During a session with Friedman on February 22, 1995, plaintiff discussed an incident at a hospital, alleging that hospital personnel "run after you like wolves to tear you apart." Defendant concluded that plaintiff continued to exhibit chronic anger and depression, and he increased plaintiff's dosage of Prozac to 40 mg per day because plaintiff was not "improving rapidly enough if at all at this point." Friedman admitted that this increase in dosage within a relatively short time was contrary to the manufacturer's recommendations as set forth in the Physician's Desk Reference ("PDR"), and he acknowledged that he had still not discussed potential side effects with plaintiff. Friedman also conceded that it takes several weeks for the maximum effect of Prozac to be realized.

On March 1, 1995, Friedman increased plaintiff's prescription of Prozac to 60 mg per day. He told plaintiff that "he wasn't getting better fast enough and that he was not a small person and that [the increased dosage] was indicated." According to Friedman, during the session on March 8, 1995, plaintiff revealed that he was angry that Bojana "was staying in Croatia longer than he had anticipated." On March 20, 1995, after Bojana had returned home, she telephoned Friedman and informed him that plaintiff "had gone berserk," had been violent, had been "breaking furniture," and was on his way to the airport to get a flight to Croatia "to kill all these people," presumably referring to the Croatian government officials involved in the unsuccessful hotel investment transaction.

Two days later, plaintiff, who had not flown to Croatia, attended his regularly scheduled session with Friedman, and Friedman observed that plaintiff seemed "more depressed." According to Friedman, plaintiff explained that Bojana had lost $85,000 in the hotel shares purchase, one of a series of bad investments. Plaintiff blamed the financial loss on the Croatian government, and he was enraged at government officials for referring to him as a "Serb," a term he considered a gross insult. Although Friedman admitted he had considered the possibility that plaintiff had experienced an episode of mania, a potential side effect of Prozac, he ultimately determined that this was an episode of rage brought on not by taking Prozac, but by plaintiff's financial problems and anger at his wife. Friedman explained that manic behavior is generally associated with an "an elevated mood, hyperactivity, lack of sleep without any side effects, loss of real[ity] . . . [and] buying sprees," none of which plaintiff exhibited.

Friedman acknowledged that Bojana called several times and asked to participate in plaintiff's therapy sessions. He denied her request, however, explaining that plaintiff was not psychotic and so "we have to respect his privacy." Moreover, according to Friedman, plaintiff never asked to have his wife included in the therapy sessions, and plaintiff was indifferent to the decision not to include her.

On March 29, 1995, Friedman observed that plaintiff appeared "remarkably better," but nevertheless noted that plaintiff's "anger" was "easily triggered by inadvertent [and] innocent comment[s] by others." Friedman admitted that during this session plaintiff expressed concern about the potential side effects of Prozac, but plaintiff did not report suffering any side effects, other than dry mouth and sexual dysfunction. Plaintiff testified to the contrary, that he had been experiencing many of the PDR-listed side effects, including sexual dysfunction, insomnia, feelings of anger, and increased irritability. Plaintiff claimed that defendant simply characterized the PDR as "baloney," explaining that the "company has to write something."

In April 1995, Midlantic Bank filed foreclosure actions against plaintiffs, seeking possession of their commercial buildings in Englewood and Jersey City. On May 17, 1995, Friedman observed that plaintiff appeared to be progressively more angry and he increased plaintiff's dosage of Prozac to 70 mg per day. Friedman also conceded that he was familiar with "the literature" which said that use of Prozac can increase anger.

On May 24, 1995, defendant increased plaintiff's dosage of Prozac to 80 mg per day, the maximum recommended amount. Nonetheless, on June 7, 1995, based in part on Friedman's favorable evaluation, Englewood Hospital reinstated plaintiff's staff privileges, albeit on a gradual and supervised basis. Friedman testified that he recommended plaintiff's reinstatement because plaintiff was "better than he was a year ago when he was perfectly acceptable to the staff of Englewood Hospital," even though he had not recovered "from his depression."

On June 12, 1995, plaintiff was arrested for causing a disturbance at a local car dealership with which he had had a longstanding dispute. Plaintiff was jailed and released later that night. When Friedman saw plaintiff for the last time on June 14, 1995, he said plaintiff was "mad at the Ford dealership who had rooked him and he was mad at the police for arresting him," and "he was mad at me" for being "rude" to Bojana. When Friedman was asked if he considered the incident at the Ford dealership to be consistent with mania, he answered: "No. I regarded him as a volcano that was simmering along and every once in a while it would have an explosion."

On June 15, 1995, plaintiff saw Sharad Wagle, a psychiatrist, who diagnosed plaintiff as manic and arranged for admission to Valley Hospital, where plaintiff remained for five days. During his hospitalization, plaintiff was treated by another psychiatrist, who diagnosed him as suffering from bipolar disorder, a diagnosis subsequently disputed by both parties' psychiatric experts. When plaintiff returned home, Bojana described his condition as unresponsive, and said this condition lasted for several days.

Plaintiff did not subsequently return to the practice of medicine. Bojana closed plaintiff's offices and wrote to each of the hospitals at which he maintained staff privileges, advising them that he was taking a leave of absence. In October 1995 plaintiff began treatment with Dr. Nicholas Marchese, a psychiatrist, who diagnosed plaintiff as suffering from post- traumatic stress disorder. Marchese explained that post- traumatic stress disorder "produces a variety of symptomatologies such as agitation, apprehension, [and] depression . . . ." Marchese opined that plaintiff had developed this disorder as a result of "the increased amounts of Prozac" prescribed by Friedman, and concluded that as a result plaintiff was "psychologically dysfunctional." Marchese admitted that he had both treated and evaluated plaintiff, but said he did so only after receiving plaintiff's permission to submit an evaluation to the Board of Medical Examiners (BME).

In May 1996, plaintiff entered into a letter agreement with the BME under which he agreed not to practice medicine pending a demonstration of his fitness and competence. At the time of trial, plaintiff testified that he was still unable to practice because he had no confidence in his abilities. He also stated that he continued to suffer from sexual dysfunction.

Dr. Harold Bursztajn, plaintiff's expert in the field of forensic psychiatry, testified that Friedman deviated from the accepted standards of care in acting as both an evaluator and treating physician. Bursztajn explained that the Academy of Psychiatry and Law provides in its ethics code that "whenever possible" a psychiatrist should not function in such a dual role because it inevitably violates confidentiality and creates a relationship of "power dependency," not trust.

Bursztajn also concluded that Friedman deviated from the accepted standards of care by increasing plaintiff's dosage of Prozac too quickly. Bursztajn explained that Prozac has an unusually slow rate of elimination half-life and thus steady states of the drug in the body are only achieved after about four to five weeks of use. Therefore, psychiatrists should only increase a patient's dosage of Prozac after six weeks of use.

Bursztajn maintained that a rapid increase in dosage is more likely to produce adverse side effects, including the most dangerous side effect, mania. Bursztajn described mania as a "very dangerous delirious state where the person begins to have pressured speech, they lose their judgment, [and] they begin to take unnecessary risks." Bursztajn concluded that plaintiff had developed mania as a side effect of taking "toxic dosages" of Prozac, finding that the June 12, 1995, car dealership incident was "clearly a manic episode." Bursztajn testified that Friedman should have immediately discontinued the use of Prozac once plaintiff began to suffer side effects and should have monitored plaintiff for signs of mania. And Bursztajn concluded that defendant deviated from accepted standards in failing to warn plaintiff about all of the potential side effects of Prozac, including mania, anxiety, nervousness, violent behavior, abnormal dreams, insomnia, and sweating.

According to Bursztajn, Friedman also deviated from the accepted standards of care by: (1) prescribing Prozac without first "creating a therapeutic alliance" with plaintiff; (2) failing to include Bojana in plaintiff's therapy sessions; and (3) failing to consider plaintiff's history, including his imprisonment in Croatia, an experience that, according to Bursztajn, had caused plaintiff to develop post-traumatic stress disorder. Bursztajn found that that condition had remained in remission until 1994, when plaintiff developed complex post-traumatic stress disorder. Bursztajn explained that:

Complex post-traumatic stress disorder refers to the complications which can occur when people are especially not just traumatized, but are subsequently re-traumatized . . . . You . . . giv[e] up. You get a sense of loss of hope, there's no future; a loss of identity, a loss of who you are and what life means to you.

Bursztajn concluded that plaintiff was "so demoralized that he will not have the energy or the stamina to be able to concentrate, to be able to make the kind of fine-grain decisions that you need to be able to [make to] be a practicing physician."

In contrast, Dr. Alexander Glassman, defendant's expert psychiatrist testified that Friedman did not deviate from accepted standards of care. Glassman alleged that the ethics code published by the American Academy of Psychiatry constitutes merely "guidelines" and does not establish a standard of care. Moreover, from his review of the record, Glassman found that plaintiff had suffered from depression, and he had been properly treated by Friedman, even though Friedman also acted as an evaluator.

Similarly, Glassman testified that Friedman had not deviated from accepted standards of care in failing to include Bojana in plaintiff's therapy sessions because "there is no accepted standard of care about whether you see a spouse or a relative." Glassman explained that generally family members are only included in therapy sessions when a patient is psychotic or suicidal, which plaintiff was not. In fact, he noted that

many people with an analytical background would frown on seeing the family because they feel it contaminates the relationship, that you want as clean a relationship with the patient where the patient can absolutely trust you and there's no question about you talking to anybody else about anything they say to you. There are other people that wouldn't feel that that's such a religious issue, that you can be flexible about it and there's no standard of care, people do different things. Part of it depends on the relationship between the patient and the spouse. Those are all issues that go into making a decision.

With regard to treatment, Glassman noted that Prozac is a "very traditional" drug used to treat depression, and concluded that such a prescription was entirely appropriate here. He also opined that defendant had not deviated from accepted standards in escalating plaintiff's dosage at the pace he did. Glassman explained that the PDR does not "set the standard of care." Instead, he described the PDR as a compilation of drug "packag[ing] inserts," representing guidelines, not standards for the administration of medication. He explained that to "some extent" the information is not entirely accurate because "drug[] companies often add stuff to the PDR to sort of protect themselves." Thus, he noted that physicians often appropriately prescribe medication in excess of PDR recommended dosages. He opined that the pace of dosage escalation was appropriate in this case given the nature of defendant's depression, his slow improvement, and his physical attributes.

Glassman admitted that mania is a potential side effect of using Prozac, but he maintained that patients generally develop mania very early in their treatment and defendant did not exhibit any signs of mania until the car dealership incident on June 12, 1995. Moreover, Glassman claimed that it is very rare for a patient who does not have an individual or family history of bipolar disease, such as plaintiff, to suffer mania as a result of Prozac use. He testified that Friedman did not deviate from the standard of care in prescribing Prozac, even though plaintiff may have developed mania, because it was "an appropriate drug to use for depression" and it was "very unlikely" to cause mania.

Moreover, Glassman concluded plaintiff's alleged inability to return to the practice of medicine was not a consequence of taking Prozac or allegedly developing mania. He explained that generally as soon as you stop taking Prozac "the mania goes away." And Glassman noted that he had never treated anyone who developed "residual symptom[s]" as a result of Prozac use, nor was there any "real description in the literature of cases where someone has . . . residual damage from these episodes." Instead, Glassman opined that plaintiff was suffering from long-standing depression-related and personality-related psychiatric difficulties.

The jury resolved the conflicting expert testimony in favor of defendant, and we perceive no legitimate basis to intervene. Based on our review of the record, we have concluded there is ample evidence to support the jury verdict, and the verdict did not constitute a miscarriage of justice under the law warranting a new trial. Dolson v. Anastasia, 55 N.J. 2, 6-7 (1969); Baxter v. Fairmont Food Co., 74 N.J. 588, 599 (1977); Law v. Newark Bd. of Educ., 175 N.J. Super. 26, 37 (App. Div. 1980); see also R. 2:10-1. Plaintiff's contentions to the contrary are without sufficient merit to warrant extended discussion. R. 2:11-3(e)(1)(B) & (C).

With respect to the summary judgment in favor of Lilly, the trial court reasoned as follows:

Plaintiff has the burden of proving that defendant[']s alleged inadequate warning was a proximate cause of injuries. Plaintiff must show that adequate warnings would have altered the doctor's decisions to prescribe Prozac. Dr. Friedman's uncontroverted testimony shows that the decision to prescribe Prozac would not have been altered by his subsequent knowledge of events or because of any alleged inadequacies in the Prozac warning label. Plaintiffs have failed to present any supportive evidence in order to defeat defendant's motion for summary judgment specifically with regard to the issue of proximate causation.

Plaintiffs have failed to show that Lilly's warning label for Prozac was inadequate. Dr. Friedman's uncontroverted testimony that Lilly produced a warning with Prozac regard[ing] [the] potential risk of mania, the very injury from which plaintiff, Dobrovic allegedly suffered. Dr. Friedman was aware of the warning and evaluated plaintiff for mania. In his medical opinion, plaintiff did not suffer from mania. The warning was thus adequate and discharg[ed] defendant Lilly's duty under the learned intermediary doctrine. Defendant Lilly's motion for reconsideration from the Court's 12/20/02 order is granted . . . .

N.J.S.A. 2A:58C-2(b) subjects a seller to liability for a product which "fail[s] to contain adequate warnings or instructions . . . ." In a failure-to-warn case the plaintiff has the burden of proving by a preponderance of the evidence that the manufacturer did not warn of the risks attendant to the product, and that the failure to warn was a proximate cause of the plaintiff's injuries. Sharpe v. Bestop, Inc., 314 N.J. Super. 54, 62-63 (App. Div. 1998), aff'd o.b., 158 N.J. 329 (1999). And N.J.S.A. 2A:58C-4 provides that

[i]n any product liability action the manufacturer or seller shall not be liable for harm caused by a failure to warn if the product contains an adequate warning or instruction . . . . An adequate product warning or instruction is one that a reasonably prudent person in the same or similar circumstances would have provided with respect to the danger and that communicates adequate information on the dangers and safe use of the product, . . . in the case of prescription drugs, taking into account the characteristics of, and the ordinary knowledge common to, the prescribing physician. If the warning or instruction given in connection with a drug . . . has been approved or prescribed by the federal Food and Drug Administration . . . a rebuttable presumption shall arise that the warning or instruction is adequate.

Lilly's warning accompanying Prozac was approved by the United States Food and Drug Administration (FDA), and the trial court concluded that plaintiff failed to rebut the statutory presumption under N.J.S.A. 2A:58C-4, that Lilly's FDA-approved warning was adequate. See Perez v. Wyeth Lab., Inc., 161 N.J. 1, 24 (1999) ("FDA regulations serve as compelling evidence that a manufacturer satisfied its duty to warn the physician about potentially harmful side effects of its product."). In this case, it is undisputed that Lilly warned of the very side effect that plaintiff allegedly experienced--a series of manic reactions while on Prozac. Accordingly, the record fully supports the trial court's determination that plaintiff failed to rebut the statutory presumption that Lilly's warning was adequate.

Affirmed.

 

Because the claims of Bojana Dobrovic are derivative, we refer to Slavo Dobrovic, M.D. as plaintiff.

Prozac (fluoxetine), an antidepressant, is a registered trademark of Eli Lilly and Company.

(continued)

(continued)

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A-4206-03T2

 

August 16, 2006