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05/27/94 JULAINE CHIRICOSTA v. WINTHROP-BREON

May 27, 1994

JULAINE CHIRICOSTA, AS MOTHER AND NEXT FRIEND OF NICHOLAS CHIRICOSTA, A MINOR, PLAINTIFF-APPELLANT,
v.
WINTHROP-BREON, A CORPORATION, MOON KIM, M.D., MARJORIE PROMBO, FLOSSMOOR COMMONS PEDIATRIC, LTD., A CORPORATION, AND ST. JAMES HOSPITAL, A CORPORATION, DEFENDANTS-APPELLEES.



Appeal from the Circuit Court of Cook County. The Honorable James E. Sullivan, Judge Presiding.

Released for Publication July 14, 1994. Petition for Leave to Appeal Denied October 6, 1994.

Egan, McNAMARA, Rakowski

The opinion of the court was delivered by: Egan

PRESIDING JUSTICE EGAN delivered the opinion of the court:

This is an appeal by the plaintiff, Julaine Chiricosta, who filed a malpractice claim on behalf of her son, from a jury verdict in favor of the defendants. She contends that the jury verdict is against the manifest weight of the evidence and, alternatively, that trial errors occurred that require a new trial.

The plaintiff's son, Nicholas, was born at St. James Hospital. Before her delivery, the plaintiff was given 25 milligrams of a narcotic drug, Demerol, to relieve pain. There were no complications during the delivery and Nicholas' condition was stable for the first five minutes after delivery. After leaving the delivery room, however, Nicholas had trouble breathing in the nursery. Two and a half hours later, Nicholas' condition did not improve and he was transferred to Rush-Presbyterian-St. Luke's Hospital (Rush). This suit focuses on those 2 1/2 hours after delivery. (The Rush team determined that Nicholas suffered from persistent fetal circulation of unknown etiology during those 2 1/2 hours after delivery.) Today, Nicholas suffers from cerebral palsy.

The plaintiff alleged that the intravenous administration of Demerol approximately 30 minutes before delivery crossed the placental barrier and caused injury to the fetus. The plaintiff also claimed that the doctors and St. James personnel who cared for Nicholas in the nursery were negligent in their treatment.

The plaintiff named the following as defendants: Dr. Thomas Iannucci, her obstetrician; Suburban Heights Medical Center, of which Dr. Iannucci was a member; Dr. Marjorie Prombo, a pediatrician; Flossmoor Commons Pediatrics Ltd., Dr. Prombo's medical group; Dr. Moon Kim, a neonatologist *fn1 who headed the nursery; St. James Hospital; Nurse Mary Pat O'Leary, Nurse Sharon Kosteroski and respiratory therapist Louis Davlantis, employees of St. James; and Winthrop-Breon (Winthrop), the manufacturer of Demerol. The plaintiff alleged negligence theories against the doctors; a respondeat superior theory against St. James for the negligence of its nurses and respiratory therapist; and strict liability theory against Winthrop.

A two month trial involved all occurrence witnesses and 12 experts. While the jury deliberated, Dr. Iannucci and Suburban Heights Medical Group settled with the plaintiff for $1.6 million. The jury found all other defendants not guilty. We will first address the plaintiff's claim that the verdict was against the manifest weight of the evidence.

The plaintiff was admitted to St. James Hospital by Dr. Dale Collins, a partner in the Suburban Heights Medical Center, at 5:40 a.m. on March. 22, 1982, for the delivery of her third child.

At 7:40 a.m., Dr. Iannucci performed a vaginal examination. He also ordered "Demerol, 25 milligrams I.V. p.r.n. for pain." (P.r.n. is an abbreviation for pro re nata meaning "as needed or as the occasion arises.") He did not order a specific time when the Demerol was to be given. He left the decision to the nurse whenever, in her medical judgment, she thought it appropriate to give it. The Demerol order was for a single dose. Based on her experience, Nurse O'Leary knew that she was to give one dose and contact Dr. Iannucci if the patient requested more pain reliever.

At about 9:30 a.m., the plaintiff's labor pains increased, and she requested something to take the edge off her pain. O'Leary administered a single dose of 25 milligrams of Demerol intravenously by slowly giving an injection in a pre-measured syringe directly into the vein. It took between 50 seconds and a minute to give the injection.

Before the plaintiff was transferred to the delivery room, the fetal heart rate was checked eight times and was within normal range of 120 to 160 beats per minute. At 9:30 a.m., before the Demerol was administered, the fetal heart tones had risen to 134-135. At 9:45 a.m., the heart rate returned to 120. After the Demerol was administered, the plaintiff did not observe any respiratory depression.

By 9:45 a.m., the cervix was fully dilated and the plaintiff was transferred from the labor room to the delivery room, accompanied by O'Leary. At 10:07 a.m., Dr. Iannucci delivered Nicholas head first. There were no complications in the delivery room, no observed abnormalities and no gross congenital abnormalities. According to Dr. Iannucci, Nicholas was breathing on his own. There were no clinical signs of respiratory depression in the delivery room, and no apparent reason to administer oxygen or use any other resuscitative measures. Nothing in the delivery room indicated that Nicholas suffered from narcotization upon delivery. Dr. Iannucci testified that he had seen babies who suffered from such a condition upon delivery and the delay they experienced in starting to breathe. He described those babies as limp or floppy without good muscle tone. They also do not cry, and their color may or may not be pink.

The one-minute and five-minute Apgar scores were made at 10:08 a.m. and 10:12 a.m. "Apgars" are named after Dr. Virginia Apgar and are a tool for a quick assessment of a newborn's condition. Five items, heart rate, muscle tone, reflex irritability, respiration and skin color, are scored 0, 1 or 2. The maximum total score is 10, which is relatively unusual, particularly at the one-minute score because it takes over one minute for the entire body, including fingertips andtoes, to become pink. O'Leary's scores for Nicholas were "8" at both the one-minute and five-minute scores, which she considered to be good scores. She gave him a score of "2" in the categories of heart rate, muscle tone, and reflex irritability and a score of "1" for respiration and skin color. For the heart rate score, a "2" would indicate a heart rate of 100 beats per minute at a minimum. For muscle tone, a score of "2" indicates that the baby is moving spontaneously. Reflex irritation refers to whether the baby has a lusty cry and responds to external stimulation, such as startle, sucking or gag reflexes. She also noted that Nicholas' throat had more mucous than she normally saw.

The respiration score was given, according to O'Leary, because Nicholas was making a "grunting" sound or low congested sound after delivery. (A score of "2" would indicate regular breathing at a rate of 35 to 50 breaths per minute and a "0" would indicate no spontaneous respiration.) O'Leary stated that a "1" is given for a slow breathing rate or some abnormal or irregular manner of breathing. O'Leary gave Nicholas a "1" for skin color, which usually refers to a baby whose body is pink but whose extremities (hands or feet) still have a bluish coloration.

Dr. Iannucci gave Nicholas a total Apgar score of "8" at the one-minute interval (with a score of "1" for respiration and skin color) and gave a "9" at the five-minute interval. Dr. Iannucci gave Nicholas a "9" because he scored respiration at "2." He thought that the grunting indicated that Nicholas was making a good respiratory effort. At trial Dr. Iannucci testified that, if Nicholas had been depressed from the Demerol after delivery, he would not have expected to see scores of "2" for muscle tone and reflex irritability.

Before Nicholas was taken from the delivery room, he was given to the plaintiff for "bonding" and was also held by the father. O'Leary testified that babies are not given to the parents to hold unless the babies are stable. According to the plaintiff, Nicholas "looked fine." The father held Nicholas for a few minutes and agreed that he looked fine; he was pink and appeared to be breathing properly.

According to O'Leary, Nicholas was in good condition when he left the delivery room. After the bonding, a nurse's aide transported Nicholas to the nursery. The father accompanied the aide and Nicholas down the hall to the nursery. As they approached the nursery, the father noticed that Nicholas' face was turning blue; Nicholas was making motions with his mouth and moving his arms and legs under a blanket.

Nurse Kosteroski admitted Nicholas into the nursery at 10:30 a.m. Nicholas' heart rate was within normal range, his respiratoryrate was 36 (normal range is between 30 to 60, his temperature was subnormal, muscle tone was fair, and his skin color was "cyanotic." Skin color and the respiratory rate indicated that Nicholas was receiving poor oxygenation of his blood. Kosteroski placed him in the "special care" section of the nursery due to his color. She deep suctioned for small amounts of mucous and fluids, using a catheter. The heart rate was 134 and his respiratory rate was 34 (with some retracting and pulling). According to Kosteroski, Nicholas was not going to sleep and did not appear narcotized. She placed him on an "Ambu bag" with a mask, which was set at 40% oxygen. An "Ambu bag" is attached to a wall unit which supplies ordinary air (21% oxygen) or 40% or even 100% oxygen. It can be attached to a mask or endotracheal tube and the rate, pressure and other parameters are established by manual operation of the bag. After Kosteroski administered the oxygen, Nicholas showed some improvement in color. She described his color as "very pale," but his condition did not improve to what she expected (he was still struggling to breathe). By 10:45 a.m., his color slightly improved to "pale," but the muscle tone was floppy and the heart rate decreased from 134 to 86. Nicholas was then placed in an incubator.

Kosteroski placed an emergency summons for Dr. Iannucci because Nicholas was in distress, was not improving and she needed help. She also placed a call to Dr. Marjorie Prombo, the designated pediatrician, and to Dr. Moon Kim, a neonatologist. Dr. Iannucci, who was on the same floor, was the first to arrive at about 10:45 a.m. He took charge of Nicholas and remained in charge until Dr. Kim arrived. Dr. Iannucci had never resuscitated a newborn in the nursery but had experience resuscitating infants in the delivery room. When he arrived, Nicholas was cyanotic and his heart rate was down to 40 to 60 beats per minute; he appeared to be floppy and barely breathing. Dr. Iannucci intubated Nicholas with an endotracheal tube and used the Ambu bag with 100% oxygen. After he intubated him, he suctioned. After attaching the Ambu bag, he periodically listened and observed Nicholas to make sure that his lungs were expanding on both sides.

Dr. Iannucci decided not to give Narcan, the antidote for narcotic-induced respiratory depression, because there had been no indication in the delivery room of narcotization or respiratory depression or that Nicholas needed resuscitation. According to Dr. Iannucci, Nicholas appeared normal and no resuscitation had been performed in the delivery room except for the usual suctioning. Dr. Iannucci also thought that the sudden change in the child's condition was inconsistent with a diagnosis of narcotization. He was aware that Kosteroskihad been using the Ambu bag with Nicholas and that, if he was suffering from respiratory depression (secondary to narcotics), he should have responded to the Ambu bag treatment. According to Dr. Iannucci, once he intubated Nicholas and reattached the Ambu bag with 100% oxygen, Nicholas should have responded immediately if this was a case of Demerol-induced respiratory depression. Dr. Iannucci first thought that Nicholas suffered from a congenital heart problem or some other problem with his lungs or heart. Then he thought that Nicholas suffered from a "delayed respiratory distress" problem. His tentative diagnoses were congenital heart disease and persistent fetal circulation secondary to pulmonary disease. Persistent fetal circulation means that the child's circulation system fails to make the transition from fetal circulation (where lungs are not used to oxygenate the blood) to post-fetal circulation (when the lungs are first used). The condition of persistent fetal circulation does not respond to oxygen therapy.

Dr. Iannucci did not think Demerol caused or contributed to Nicholas' condition because Nicholas showed no signs of a typical case of respiratory depression due to medication. Nicholas' condition deteriorated over 30 minutes after delivery. Dr. Iannucci testified that in his experience, narcotized babies are slow to develop sustained, rhythmical breathing; they usually do not cry; and they are sleepy. Nicholas did not share these characteristics because his Apgar scores were "8" at the one-minute and five-minute intervals. Even if narcotization is delayed, it usually is apparent at the five-minute Apgar interval, because after the adrenaline from the birth process decreases, the baby's respiration tends to drift off slowly between the one and five minute Apgar scores.

Louis Davlantis, a certified and registered respiratory therapist, was summoned and arrived shortly before 11 a.m. He placed Nicholas on the ventilator at 11 a.m. with 60% oxygen and set pressure, inspiratory/expiratory ratio, rate and flow gauge per Dr. Iannucci's order. The flow was set to compensate for a minimal "air leak," i.e., air returning from the lungs along the outside of the tube; such a leak is desirable for a newborn. Davlantis listened to Nicholas' breath sounds and watched his chest rise and fall. There was no improvement in Nicholas' color. At 11 a.m., Dr. Iannucci ordered adrenaline and Atropine and the heart rate increased to over 100. A chest x-ray was ordered at 11:07 a.m.

At 11:02 a.m., Dr. Marjorie Prombo arrived and examined Nicholas. His color had returned to cyanotic and his nail beds were dark. At 11:05 a.m. he was "gaspy"; he was making a respiratory drive effort separate and apart from the ventilator machine. Cardiac and respiratory monitors were attached and the heart rate was 107.

Dr. Prombo was in the nursery for eight minutes when Dr. Kim arrived and took charge at 11:10 a.m. (Dr. Iannucci left about 10 minutes later.) Dr. Kim discussed the labor and delivery with Dr. Iannucci upon arrival. He also learned that the plaintiff had been given 25 milligrams of Demerol 37 minutes before delivery.

Dr. Kim first learned that Demerol was an obstetrical analgesic when he was a pediatric resident. Prior to March 1982, he read the 1982 package insert or PDR for Demerol, which contains "indications" i.e., what the drug can be used for, and "contraindications," i.e., how the drug should not be used. Although not an obstetrician, he needs to know about drugs given to the mother so that he can treat a baby who might have a drug-related problem. He knew that (1) Demerol, when used as an obstetrical analgesic, crosses the placental barrier and can produce depression of respiratory and psychological functions in the newborn; (2) Demerol is a narcotic analgesic and the major hazards include respiratory depression and circulatory depression (to a lesser degree), and that respiratory arrest, shock, and cardiac arrest have occurred; (3) when used as an obstetrical analgesic, the usual dose of Demerol is 50 to 100 milligrams given intramuscarlarly or subcutaneously; and (4) if Demerol is given intravenously, it should be given slowly and diluted or given in a reduced dosage. He also knew that the primary treatment for narcotic-induced respiratory depression is to reestablish an adequate respiratory exchange through a patent airway and assisted ventilation. He knew that the antagonist (or antidote) for Demerol was Narcan (naloxone hydrochloride) and that an appropriate dose should be administered simultaneously with respiratory resuscitation (primarily by the I.V. route).

Dr. Kim's opinion was that Nicholas was not suffering from respiratory depression and specifically not respiratory depression caused by the use of Demerol. He based this opinion on (1) the history; (2) the Apgar scores; (3) the fact that Nicholas did not appear to be suffering from respiratory depression at the time of delivery; (4) the dosage of Demerol; and (5) the fact that Nicholas did not exhibit respiratory problems until after delivery. He opined that Nicholas' problems were not related to the Demerol and saw no reason to administer Narcan.

When Dr. Kim arrived in the nursery, Nicholas was suffering respiratory distress and serious shock. His color was cyanotic. Dr. Kim ordered 100% oxygen from the ventilator and changed the inspiratory/expiratory rate from 1/1.5 to 1/1.1. He checked the position of the endotracheal tube and pulled it back a bit, then taped it in place. He also obtained an x-ray to make sure that the tube wasin the correct position. The x-ray was taken at 11:40 a.m. It confirmed that the tube and arterial umbilical line were in the correct position and that the lungs were being filled with oxygen. The x-ray also indicated hyperaeration, demonstrating that the oxygen mixture from the tube was travelling through his lungs. Even though Nicholas' lungs were filled with oxygen, the blood gasses indicated that oxygen was not getting into the blood. He placed an arterial umbilical I.V. line at 11:20 a.m. so that blood samples could be taken, and so that medications and fluids could be administered. At 11:30 a.m., Nicholas' respiratory rate was 38, his heart rate was 168, and Kosteroski noted that he was warm.

At 11:55 p.m., Nicholas' color improved; he appeared more pink. Dr. Kim continued to check the aeration by listening and observing chest movement. At 12:18 p.m., Nicholas' color was "terrible again" and cyanotic, according to Kosteroski. Dr. Kim removed him from the respirator, used the Ambu bag (but there was not much change in color) and then reconnected him to the ventilator.

From the time of Dr. Kim's arrival, Nicholas was breathing on his own or with assistance. At times, he was gasping on the respirator. Gasping is an indication that the baby is struggling to breathe and that the respiratory drive is still working. Dr. Kim continued to work with Nicholas until shortly after 1 p.m. when the Rush team arrived and assumed the care of Nicholas. Dr. Kim briefed the Rush team and informed them of the administration of Demerol to the mother.

As part of the transfer to Rush, arrangements were made to have a copy of Nicholas' charts made (including the labor and delivery progress summary) and given to the Rush transfer team. Nicholas remained at Rush for approximately 3 1/2 to 4 weeks. Rush determined that during the first few hours after his birth, Nicholas suffered from a condition known as persistent fetal circulation of unknown etiology. As a result, he suffered from cerebral palsy.

We will discuss the evidence involving the claim against each defendant individually. The first claim will be that against the defendant, Winthrop, the manufacturer of Demerol. The plaintiff's claim against Winthrop is based on the allegation that Winthrop's label on Demerol failed to warn of the dangers of the administration of Demerol.

Dr. Zane Brown, the plaintiff's expert, gave the opinion that, although Demerol is a drug that is not unreasonably dangerous, the labeling did make it hazardous to obstetrical patients. He said that the label was inadequate because (1) it did not specify an intravenous dosage that should be given when a woman is in labor; (2) it gave nodescription of the pharmacokinetics of the drug regarding its entry into the mother and then the baby (and its metabolization); (3) it did not apprise the doctor that a newborn baby may initially have good Apgar scores and then the baby could still "crash"; (4) it did not say how or how much of the antagonist, Narcan, to administer; (5) it did not specify the dosage of Narcan that might have to be repeated; and (6) it did not explain that resuscitation of a baby is different from that of an adult.

Although Dr. Brown made numerous criticisms of the label, on cross-examination, serious questions of his qualifications were raised. He admitted that he never participated in a labeling program; that he had no knowledge of regulations of the Food and Drug Administration (FDA) concerning the marketing and labeling of drugs, the development of a package insert or its placement in the Physicians Desk Reference Book (PDR) *fn2; that he did not know whether the FDA would permit a drug company to put a recommended dosage of Narcan in the Demerol package insert or if the FDA would permit pharmacokinetic information on the label; that he was not qualified to say what should be put on the label; and that he was not an expert on labeling.

On cross-examination Dr. Brown also said that he was not qualified to say what should go into a package insert, but that he just needed to know the specifics that he read in the PDR. The attorney for Winthrop then read Dr. Brown's answer at his deposition:

"I don't think I am qualified to give you an opinion as to what should be included in the package stuffer or what shouldn't be included in the package stuffer. I mean, there [are] professionals that write that and have strong guidelines as to what should be included."

Dr. Brown knew nothing about FDA regulations concerning drug labeling, was not an expert in pharmacokinetics, had no experience with the use of Demerol since 1977 and had never written any articles or conducted any research on Demerol. More importantly Dr. Brown conceded that no report or study had ever stated that 25 milligrams of Demerol is likely to create (or is a sufficient dose) to cause the respiratory problems that Nicholas encountered after birth.

Another expert called by the plaintiff, Dr. Philip Walson, testified that the label should have stated: "If any signs of narcotic effect are seen in the newborn, give Narcan." He also said that the onset and recognition of the onset of the narcotic effect may not be present inthe delivery room but could later occur after the infant left the delivery room. (This is the "masked effect.") On cross-examination Dr. Walson admitted that he did not do any research on Demerol as an obstetrical analgesic. He agreed that articles from various studies reported that 50 milligrams of Demerol given intravenously within one hour of delivery found no observable signs and little likelihood of respiratory depression in the newborn. He did not know whether the same recognized text, to which he referred on direct examination, made any mention of a delayed onset of respiratory depression. He did not publish any article on the same subject. He also agreed that the Demerol label did not state that respiratory depression cannot occur if the Apgar scores are good or that it could occur within a particular time. Dr. Walson also said that persistent fetal circulation has no cause, is not drug-induced and rarely responds well to any treatment.

Dr. Sol M. Shnider was called as an expert on behalf of Winthrop. He is board-certified in anesthesiology and began to specialize in obstetrical anesthesiology in the late 1950's. He had done extensive research in the area of obstetrical anesthesia and analgesia, including studies on the effects of Demerol on the mother and fetus. He had never read any articles or textbooks that state that 25 milligrams of Demerol given to the mother could cause respiratory depression in the newborn. He explained that the so-called "delayed effect" of Demerol was not a delay in onset but a question of a delay from the time of administration of the drug to the mother to the time of delivery. Where the drug is given one to four hours before the delivery, it accumulates in the baby's system, resulting in some instances, in respiratory depression at birth; if the same dosage is given less than one hour before the delivery, it does not result in respiratory depression at birth.

It was his opinion that the package insert for Demerol was adequate and informed and warned physicians who used Demerol of the potential risk to the mother, fetus and newborn child, that it adequately warned about respiratory depression of the newborn after it was in obstetrics and that the insert did not cause or contribute to the condition of Nicholas. It told doctors that Demerol both causes or could cause respiratory depression, that resuscitation may be required and that an antidote may be necessary. It also listed and warned of possible side effects of Demerol. He agreed that the page insert did not warn of a "delayed effect" because "a delayed effect doesn't exist."

We believe that the jury did not act unreasonably when it apparently accepted the opinion of Dr. Shnider and rejected theopinions of Dr. Brown and Dr. Walson. For that reason, we conclude that the verdict of the jury on behalf of Winthrop was not against the manifest weight of the evidence.

The plaintiff alleged two acts of negligence against Dr. Kim: the failure to reintubate Nicholas because the endotracheal tube was an inappropriate size, and the failure to give Narcan. Dr. Brown and Dr. Marcus Hermansen, another expert called by the plaintiff, criticized Dr. Kim for leaving an inappropriately small endotracheal tube in place. Both Dr. Brown and Dr. Hermansen agreed that if ventilation is being accomplished, the size of the endotracheal tube is of no import. The evidence established that ventilation was being accomplished; the x-ray showed radiolucent lungs that were filled with air. Thus, the endotracheal tube that was in place was aerating the lungs. Dr. Hermansen also conceded that Narcan was not necessary because Nicholas was already on a ventilator when Dr. Kim arrived in the nursery. So long as the lungs were being aerated, Narcan was not needed.

Dr. Henry Mangurten, an expert called by Dr. Kim, testified that Dr. Kim complied with the standard of care, that he did not cause Nicholas any harm and that every step Dr. Kim took helped Nicholas. Again we conclude that the jury was justified in accepting the testimony of a defendant's expert and rejecting those of the plaintiff. The verdict in favor of Dr. Kim is not against the manifest weight of the evidence.

The plaintiff's charge of negligence against Dr. Prombo and her medical group, Flossmoor Commons Pediatrics, Ltd., was based on allegations similar to those made against Dr. Kim: Her failure to change the endotracheal tube and her failure to administer Narcan. Dr. Prombo, was in the nursery for approximately eight minutes. She obtained a full history, and after she physically examined Nicholas, Dr. Kim entered the nursery and took charge. Dr. Prombo did not give any orders when Dr. Kim took over the care of Nicholas. She also presented an expert Dr. Richard Burnstine, who testified that Dr. Prombo did not violate the standard of care. He testified that it was reasonable for Dr. Prombo not to have taken charge of Nicholas because the tube was put in and the drugs were administered immediately before she arrived in the nursery. Since there was nothing about the care that was being rendered that would require a pediatrician to correct, there was no reason for Dr. Prombo to usurp the authority of the doctor in charge of Nicholas. The verdict of the jury in favor of Dr. Prombo was not against the manifest weight of the evidence.

The plaintiff's allegations of negligence against St. JamesHospital were based on allegations against Nurses O'Leary and Kosteroski and the respiratory therapist Davlantis. The plaintiff alleged that O'Leary's conduct deviated from the standard of care in three respects: (1) when she administered Demerol to the plaintiff intravenously, she failed to first receive a specific order from Dr. Iannucci to do so; (2) she allowed Nicholas to become hypothermic; (3) she failed to verbally communicate to the nursery room staff that the plaintiff had received Demerol before delivery.

Dr. Brown testified that O'Leary was required to call Dr. Iannucci before she administered the Demerol. Dr. Iannucci testified that he ordered a single dose for the plaintiff; the order provided that the precise time the dose was to be administered was left to the discretion of the nurse. O'Leary administered the Demerol at 9:30 a.m. following Dr. Iannucci's order. Dr. Iannucci testified that if O'Leary had consulted him at that time he would have ordered the 9:30 a.m. dosage. Even Dr. Tomasi, another expert called by the plaintiff, disagreed with Dr. ...


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