On appeal from the Superior Court of New Jersey, Law Division, Middlesex County, Docket No. L-5951-06.
NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
Before Judges Ashrafi, Nugent and Kestin.
In this medical malpractice action, plaintiff, Judy Komlodi, appeals from a judgment of no cause for action entered on a jury verdict in favor of defendants Ann Picciano, M.D. and JFK Medical Center (JFK). The jury determined that plaintiff had proved by a preponderance of the evidence that Dr. Picciano deviated from accepted standards of family practice during her treatment of plaintiff's daughter, Michelle Komlodi,*fn1 and that Dr. Picciano's deviation increased the risk of harm posed by Michelle's pre-existing condition; but failed to prove that the increased risk was a substantial factor in producing the ultimate harm or injury suffered by Michelle. We reverse and remand for a new trial.
The following facts were adduced at trial. On August 2, 2004, thirty-one-year-old Michelle suffered an anoxic (oxygen depriving) brain injury after orally ingesting the drug fentanyl from a Duragesic patch that Dr. Picciano had prescribed for Michelle to attach to her skin to reduce pain in her lower back. Because Dr. Picciano's knowledge of Michelle's medical history is central to the disputed issues in this action, we begin with her doctor/patient relationship with Michelle.
Michelle's mother, Judy, arranged to have her daughter consult with Dr. Picciano. Judy was employed by JFK in the medical records office from 1989 to 1993. Dr. Picciano had practiced family medicine at JFK since 1990. Following Michelle's release from a drug rehabilitation treatment center in 1990, Judy referred Michelle to Dr. Picciano.
Michelle consulted with Dr. Picciano on June 24, 1991, for, among other things, a gynecological checkup. Dr. Picciano reviewed Michelle's charts, learned that "she had made [a] suicide attempt or gesture and that she had problems with alcohol and drug abuse," and noted that she had been in treatment for drug addiction and depression on several occasions in 1989 and 1990. During the consultation, Dr. Picciano observed no evidence of Michelle abusing drugs. Nevertheless, the doctor asked Michelle to return in July so that she could confirm or rule out the possibility that Michelle was suffering from major depressive disorder.
Michelle returned to Dr. Picciano on July 12, 1991. Concerned that Michelle was suffering from depression and anxiety, Dr. Picciano referred Michelle to a mental health center. When Dr. Picciano saw Michelle in November 1991, Michelle "seemed much better[,]" and she showed no signs of abusing drugs. Michelle saw Dr. Picciano four more times in 1992. During the last visit in December 1992, Dr. Picciano found no evidence that Michelle was using drugs. Dr. Picciano did not see Michelle for the next eleven-and-one-half years.
Sometime in 2002, Michelle began to use heroin. In November 2003, in an attempt to rid herself of her addiction, Michelle somehow obtained Suboxone, which was used to treat opioid dependence, and moved to Nevada with her ex-boyfriend. About six weeks later, in January 2004, Michelle returned to New Jersey, no longer addicted to heroin, and appearing healthier than when she had left for Nevada; but she began to work as a bartender and was consuming alcohol. Concerned about Michelle's history with drug abuse and continued alcohol consumption, her mother arranged for Michelle to return to Dr. Picciano. Judy told Dr. Picciano about Michelle's heroin use, which Michelle had discontinued six months earlier.
On June 7, 2004, Michelle presented at Dr. Picciano's office with complaints of insomnia, anxiety, depression, fatigue, palpitations, shortness of breath, back pain lasting six months, and prior "passive suicidal ideations." Michelle acknowledged using alcohol. She explained to Dr. Picciano that her back pain "fluctuates in severity," and that ibuprofen, Aleve, Advil, and Tylenol were not effective in relieving her pain. To obtain relief, she was applying a fentanyl or "Duragesic" patch, which she had obtained from a friend.
A Duragesic patch is applied to skin and contains fentanyl, a strong pain relief medication. Duragesic is the brand name of the patch, which is generically called a fentanyl patch. The patch's membrane causes the gradual release of fentanyl, which is absorbed through the skin over a seventy-two-hour period. For disposal after use, the manufacturer recommends that the patch be folded in half and flushed down the toilet, because the patch retains a potentially lethal dose after the seventy-two-hour period. This surplus of fentanyl is engineered into the patch to "drive the medicine through the membrane" that allows the fentanyl to be released. Fentanyl suppresses respiratory function when too much is taken.
Dr. Picciano did not ask Michelle how she was using the patch, and she assumed that Michelle used it properly by applying it to her skin. The only evidence adduced about Michelle's use of the fentanyl patch was from her roommate and boyfriend, Brian Firestone, who stated that she "wore [the patch] on her skin[,]" specifically on her back, and that he had never seen her put it in her mouth.
Dr. Picciano was unable to reproduce Michelle's lower back pain during the June 7 visit. Michelle did not complain of pain, she had full range of motion, Dr. Picciano's clinical examination of Michelle was negative, and her x-rays were normal. The doctor "didn't notice a patch" on Michelle's body. Dr. Picciano ordered blood tests to test liver function and for hepatitis, a virus "common in drug users."
That Michelle might be "drug seeking" may have crossed Dr. Picciano's mind. The doctor knew that Michelle had stopped using heroin before her lower back pain had begun, and she also knew that "body aches and pains," anxiety, and depression are symptomatic of drug withdrawal. Additionally, Michelle's medical history from 1992 to 2004 revealed that Michelle had visited the JFK Family Health Center about five or six times, but had not complained of orthopedic problems during those visits. Nonetheless, Dr. Picciano "didn't think [Michelle] was drug seeking." Michelle exhibited no drug-seeking behavior nor "any of the signs or symptoms" of drug withdrawal.
While trying to determine what was causing Michelle's back pain, Dr. Picciano considered that Michelle's depression, anxiety, and "passive suicidal ideations" might be manifesting as back pain. A countervailing consideration was that Michelle's involvement in an automobile accident "the summer before" was a possible source of the back pain. Regardless of the pain's cause, Dr. Picciano determined that Michelle needed help from a specialist, and gave Michelle the telephone numbers for Rutgers Behavioral Health and JFK Behavioral Health.
On June 10, 2004, Dr. Picciano telephoned Michelle to discuss some test results. On June 18, Judy informed Dr. Picciano that Michelle was not eligible for treatment at Rutgers, and would not be seen at JFK Behavioral Health for several weeks. Judy requested medication for Michelle to allow her to function normally until her appointment, and offered to administer medication to Michelle when necessary. Dr. Picciano "reluctantly" prescribed the anti-depressant Zoloft. She emphasized to Judy "the importance of no alcohol and monitoring her for suicidality" while Michelle was taking Zoloft. Dr. Picciano also stressed the need for Michelle to keep her appointment at JFK Behavioral Health.
During her July 22, 2004 appointment with Dr. Picciano, Michelle said she had missed the appointment at JFK Behavioral Health. Michelle complained of lower back pain at a level of nine on a ten-point scale. She was taking Percocet "a couple of times per week to get through work[,]" and also consuming alcohol, probably more than ten drinks daily. When unable to obtain Percocet from a friend, Michelle drank alcohol to function through the pain. Dr. Picciano did not know whether Michelle mixed the Percocet with alcohol, but assumed that she "probably" did. Michelle had taken all the Zoloft. Dr. Picciano believed that Michelle was deteriorating, "getting back into her addictions." Dr. Picciano was again unable to discern any signs of back pain. Michelle had full range of motion and no tenderness. The doctor thought that Michelle was drinking and taking Percocet because of multiple psychiatric problems that were not being treated appropriately, because she had an addiction, and because she believed that Michelle "really had back pain."
Dr. Picciano and Michelle discussed treatment options, and the doctor emphasized the importance of Michelle undergoing treatment for her psychiatric and addiction problems. Although Dr. Picciano believed that Michelle was experiencing pain, she also believed that Michelle "had no insight into her psychological issues" as the cause of the pain, which needed to be treated by a specialist. The doctor decided to treat Michelle's pain temporarily until August 1 when Michelle had an appointment at JFK Behavioral Health.
Michelle explained to Dr. Picciano that she had still been using Duragesic patches and Percocet, and only used alcohol when neither the patch nor the Percocet was available. Dr. Picciano believed that Michelle would not consume alcohol if prescribed a Duragesic patch because Michelle had been honest with her in the past and because Michelle's "drug of choice was a narcotic," not alcohol. The doctor prescribed Michelle ten Duragesic patches to temporarily manage Michelle's pain, each containing seventy-five micrograms of fentanyl. Since each patch lasted three days, a supply of ten patches would last Michelle one month, which would "bridge" Michelle to her appointment with JFK Behavioral Health. Dr. Picciano did not explain to Michelle how to open a Duragesic patch, and "usually rel[ied] on the pharmacist's [or the manufacturer's] instructions" rather than "giv[ing] every patient instructions on how to open their medication."
The Physician's Desk Reference (PDR) product description of a Duragesic patch warned that the "concomitant use" of opioids and alcoholic drinks "may produce additive depressant effects" and may cause hypoventilation, hypotension and profound sedation or coma. The fentanyl dose must be halved if a person using the patch will be drinking alcohol. The PDR also warned that respiratory failure could occur at any time during a patient's use of the Duragesic patch, and that the patch should be used with caution in those with a history of drug or alcohol abuse, especially for outpatient care.
When Dr. Picciano prescribed the patch, she explained to Michelle that she "absolutely couldn't drink alcohol when she was taking this," and Michelle assured the doctor that alcohol was not a problem because she could function without alcohol if she had a Duragesic patch. Had Dr. Picciano known that Michelle would continue using alcohol, she would not have prescribed the Duragesic patch.
On July 29, 2004, Judy telephoned Dr. Picciano and said Michelle had been "binging" on alcohol and was complaining that her stomach felt as though it were "torn apart." Dr. Picciano was "horrified" that Michelle was consuming alcohol. She instructed Judy to take Michelle to the JFK emergency room, but did not mention that she had prescribed the patch. Dr. Picciano did not know that Michelle had yet to obtain the patch. After talking with Judy, Dr. Picciano informed the attending emergency room physician at JFK, Dr. Sherrod Patel, a colleague in her group, "about Michelle's case," and told Dr. Patel to expect Michelle in the emergency room. She told Dr. Patel that Michelle required psychiatric intervention, and that he should try to transfer her to "any kind of inpatient unit."
When Michelle presented to the emergency room, her blood alcohol level was .36 and she tested positive for cocaine. Michelle told intake unit personnel that Dr. Picciano had given her a "fenetil" prescription for "outpatient detox," but she had yet to fill it. She was admitted overnight and discharged the next day. During the night, Michelle complained of back pain and was given Percocet, Ambien, Librium, Tylenol and Oxycodone.
On August 2, 2004, Michelle and her boyfriend each consumed a quarter pint of vodka and a quarter pint of brandy. Later that day, Michelle's mother drove Michelle to a Shop-Rite Pharmacy to obtain the patch. The pharmacist telephoned Dr. Picciano's office to request approval to change the prescription to five patches because Michelle could not afford the $500 cost of ten. After referring to Michelle's medical chart, a doctor with Dr. Picciano's group approved the request. Dr. Picciano had not noted in the chart that Michelle should not take fentanyl due to her hospitalization for alcohol use on July 29.
After filling the prescription, Michelle accompanied her mother and her mother's two-year-old granddaughter to her mother's medical appointment, so that Michelle could watch the granddaughter in the waiting room. While there, Michelle began to bite a Duragesic patch, trying to open it, and asked her mother for scissors. Her mother told her to open the patch at home, then left to see the doctor.
Shortly thereafter, the receptionist observed Michelle "passed out" in the waiting room, and informed another doctor. The doctor found Michelle unconscious, blue, not breathing, and without a pulse. The doctor carried Michelle into another room, where he found "a wadded piece of plastic in [Michelle's] mouth." Upon closer examination, he found that it was a Duragesic patch. He did not recall whether the patch was punctured, but described it as "chewed up." He resuscitated Michelle, and hooked her up to monitoring devices. She was put on a ventilator and taken to Raritan Bay Medical Center.
Plaintiff's expert, John Russo, M.D., was board certified in internal medicine. According to Dr. Russo, Dr. Picciano deviated from accepted medical standards of care in several ways. First, when she assumed that "over-the-counter medications will not improve the patient's complaints of back pain [when] she doesn't know historically what the duration of use, dosage or frequency of administration had been when the patient allegedly tried the medications[.]" Because Michelle presented to Dr. Picciano "without an urgent or emergent clinical finding of back pain," the standard of care required the doctor to institute a course of physical therapy, including application of hot compresses to the patient's back where the pain was occurring, taking a hot shower, and using an electric heating pad. Additionally, over-the-counter medications, such as Tylenol, should have been used long enough to determine whether they would reduce plaintiff's back pain. Dr. Russo testified that medications such as Motrin, Advil, or Aleve should have been used for a period of seven to ten days, and the patient should have been educated about the length of time it would take to determine whether heavier medications were necessary.
Dr. Russo testified that Dr. Picciano had an obligation to be familiar with the PDR warning that [t]he concomitant use of other central nervous system depressants including other opioids[,] sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, sedating antihistamines and alcoholic beverages may produce an additive depressive effect, hypo-ventilation, hypo-tension and profound sedation or coma . . . when such combined therapy is contemplated. The dose of one or both agents should be reduced by at least fifty percent.
Dr. Russo explained that alcohol would "potentiate the effect" of fentanyl from the Duragesic patch, that is, "it would be as if the dose had been doubled or tripled," and would thereby impair the body's ability to breathe. Dr. Russo further explained that because the amount of fentanyl in the Duragesic patch was the equivalent of "close to eighty Percocet," Duragesic patches were very desirable to addicts. Accordingly, the PDR warned that "Duragesic [patches] should be used with caution in individuals who have a history of drug or alcohol abuse especially if they are outside a medically controlled environment." Dr. Russo opined that Dr. Picciano should have been aware of those warnings.
Dr. Russo had been aware as early as 2004 that, though the patch was intended to be applied to the skin so that the fentanyl could be released over several days, addicts were puncturing the gelatinous material and putting it in their noses or mouths, thereby "enormously increas[ing] . . . the potency[, and] the danger is enormous because it's a very, very high dosage of the medication that . . . addicts unfortunately will . . . desire." Accepted standards of medical ...