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Vargas v. Ledon

August 19, 2009


On appeal from Superior Court of New Jersey, Law Division, Union County, Docket No. L-3331-04.

Per curiam.


Argued June 2, 2009

Before Judges Fuentes, Gilroy and Chambers.

In this medical malpractice action, plaintiff Alverio Vargas*fn1 appeals from a no cause jury verdict in favor of defendant, gastroenterologist Ramon Ledon. Plaintiff alleged Dr. Ledon negligently prescribed excessive amounts of a steroid known as prednisone, causing him to develop avascular necrosis of the hips. Plaintiff thereafter underwent multiple surgeries to address the problem. Plaintiff also alleged that he did not make an informed decision to submit to this treatment, because Dr. Ledon did not adequately apprise him of the risks associated with the prolonged use of this steroid.*fn2

Plaintiff now appeals arguing that the trial court: (1) improperly limited the testimony of his rheumatology expert; (2) failed to give Scafidi and Gardner jury charges;*fn3 (3) committed numerous errors that distracted and prevented the jury from fairly evaluating the evidence showing that Dr. Ledon deviated from the relevant standard of care; (4) improperly admitted a defense expert's net opinion; and (5) failed to provide a curative instruction to counterbalance defense counsel's inappropriate statements on summation.

We reject these arguments and affirm. We derive the following facts from the evidence presented at trial.


On January 27, 2000, plaintiff consulted with a gastroenterologist identified in the record as Dr. Delgado, complaining of lower abdominal and colic-like pain, diarrhea, and rectal bleeding.*fn4 On February 7, 2000, Dr. Delgado ordered plaintiff to undergo a colonoscopy. At a follow-up visit ten days later, Dr. Delgado diagnosed plaintiff as suffering from pancolitis, a form of ulcerative colitis.

According to Dr. Daniel H. Present, plaintiff's expert witness in the field of gastroenterology, ulcerative colitis is a disease involving inflammation of the lining or mucosa of the colon or large intestine. This type of inflammatory bowel disease ("IBD") is "fairly rare." It most commonly affects people in their late teens or early twenties, producing such symptoms as abdominal discomfort, diarrhea, bleeding, severe weight loss, and fevers. The inflammation usually starts in the rectum and may extend into the upper parts of the colon.

Because of its complexities, gastroenterologists are, ordinarily, the only physicians who care for persons suffering from ulcerative colitis. Persons diagnosed with ulcerative colitis face life-long hardship. Although it can be managed, under the current status of scientific achievement, ulcerative colitis remains incurable.

Pancolitis refers to the inflammation of the entire colon. Dr. Delgado initially treated plaintiff's pancolitis with daily dosages of three grams of Azulfidine and forty milligrams of prednisone. Azulfidine is a combination of a sulfa antibiotic and a relative of aspirin called five-aminosalicylic acid ("5-ASA"), also described as a sulfa aspirin combination of acetyl salicylic acid and sulphasalazine, which was a standard therapy for IBD at the time.

Prednisone is a synthetic corticosteroid, which can be used to treat inflammation. Dr. Delgado instructed plaintiff to take forty milligrams a day of prednisone for two weeks, thirty milligrams a day for the next two weeks, and then twenty milligrams a day for two weeks. Plaintiff next visited Dr. Delgado on March 30, 2000. According to plaintiff, he ran out of prednisone ten days earlier, and complained of cramping pain and more frequent stools. Dr. Delgado prescribed another 120 ten-milligram tablets of prednisone, and instructed plaintiff to take four tablets per day. Plaintiff was to return in two months. Plaintiff did not see Dr. Delgado again, stating at trial that he did not "trust in him."

Plaintiff's first encounter with Dr. Ledon occurred on October 31, 2000, approximately six months after he last saw Dr. Delgado. He was thirty-three years old at the time. Plaintiff characterized this visit with Dr. Ledon as merely seeking a second opinion of Dr. Delgado's diagnosis and treatment mode.

Dr. Ledon is board certified in internal medicine and gastroenterology. At the time he saw plaintiff, he had a private practice in gastroenterology. Plaintiff advised Dr. Ledon that he had been treated by another gastroenterologist who prescribed three milligrams of Azulfidine and forty milligrams of prednisone a day. This treatment had not resulted in much improvement, and plaintiff was also suffering from the side effects of the prednisone, including anxiousness and tremulousness. Plaintiff's complaints to Dr. Ledon included diarrhea, small weight loss, and lack of normal bowel movements, including bleeding. Plaintiff told Dr. Ledon that he had unilaterally stopped taking the medications prescribed by Dr. Delgado a month earlier. Plaintiff also gave Dr. Ledon the film from the colonoscopy study ordered by Dr. Delgado.

Dr. Ledon reviewed the results of plaintiff's colonoscopy, performed abdominal and rectal examinations, and found blood in the stool. He also ordered a base-line blood work-up; the lab results were normal. Dr. Ledon did not prescribe corticosteroids at this time. On November 15, 2000, Dr. Ledon performed a colonoscopy to personally examine plaintiff's colon. The colonoscopy revealed changes consistent with "mild to moderate ulcerative colitis, pancolitis."

At trial, Dr. Ledon testified that the mildest form of ulcerative colitis involved only the rectum; the disease could spread, however, to the splenic flexure (left-sided colitis) and the entire colon (pancolitis). Those suffering from the most serious form of the disease were more likely to develop "toxic megacolon or a fulminant colitis," which did not respond to any medications, and had a seventy-to-eighty-percent mortality rate, with a twenty-fold increased risk of developing bone cancer after seven years. Patients who developed cancer required a colectomy. In his twenty years of practice, he had only two patients who needed a colectomy.

According to Dr. Ledon, he made it a practice to tell his patients with ulcerative colitis that their condition could only be managed, not cured. Thus, he considered a successful outcome when a patient kept his or her colon, without developing cancer. Because of the risks involved, he also told his patients that they could not "play" with their medications, and had to follow his directions strictly. If a patient were to stopped treatment on their own, the disease would "flare," causing toxic megacolon.

After the outpatient colonoscopy, Dr. Ledon prescribed Asacol, a non-steroid 5-ASA compound. Both Dr. Ledon and his expert witness in the field of rheumatology described Asacol as a standard therapy for colitis. This was a newer drug without sulfa antibiotics and its concomitant side effects. Dr. Ledon explained that he did not prescribe Azulfidine because it did "bad things to the sperm count in men," was less effective, and had more side effects. He also did not prescribe steroids because they should not be taken long term. In this case, plaintiff did not need steroids because he had minimal bleeding and moderate colitis with no abdominal findings to suggest otherwise.

Dr. Ledon next saw plaintiff on December 1, 2000. Plaintiff reported having regular bowel movements. He was taking the Asacol as prescribed, which he said was helping. Dr. Ledon continued the medication, adding only a multi-vitamin with iron. Plaintiff returned to Dr. Ledon On January 5, 2001, complaining of bloody bowel movements for the past four weeks, up to six per day. This left him feeling very weak, tired, and without an appetite (he had not eaten for the past two days); he also had very dry lips.

Dr. Ledon's examination revelaed that plaintiff was "severely tender" and had "localized rebound," meaning severe inflammation. He administered an intramuscular injection of steroids, and prescribed sixty milligrams of prednisone (two tablets of ten milligrams each three times a day) for two weeks, along with Metronidazole, an antibiotic. Plaintiff continued to take prednisone as prescribed for two weeks. Thereafter, his prescription indicated that he was to take thirty milligrams (1 tablet of ten milligrams three times a day) for another two weeks. Plaintiff refilled his prescription on February 2, 2001, and again on April 3, 2001. Plaintiff testified that he only followed Dr. Ledon's instructions, and did not read the directions from the pharmacy.

Dr. Ledon testified that he would normally prescribe corticosteroids for patients with ulcerative colitis, "[o]n every flare." Some patients would flare once every two to three years, and others flared the moment they were taken off a steroid. In these cases, he usually prescribed sixty milligrams, and often used that dose to treat cases of severe allergic reactions. However, he would try to get the patients off the drug as quickly as possible. Dr. Ledon testified that he told plaintiff that, depending on his response, he was going to taper him off the prednisone.

According to Dr. Ledon, he discussed with plaintiff the side effects of prednisone, explaining that plaintiff needed to be followed closely to check his blood sugar and to prevent or address any side effects. It was thus his office practice to walk the patients to the front office, tell the secretary to schedule the patient for a return visit, give the patient a card indicating the date of the next visit, and check off the diagnosis and new appointment date on the chart. Plaintiff disputed this testimony; he did not recall Dr. Ledon ever telling him about the risks or benefits of taking prednisone, or of the availability of other treatment options.

At trial, Dr. Ledon produced his billing sheet for plaintiff's visit of January 5, 2001. This record indicated that plaintiff was told to return in two weeks in the morning hours so the doctor could draw his blood and analyze it for sugar content. However, Dr. Ledon's patient chart did not indicate that plaintiff was to return in two weeks. In fact, plaintiff did not see Dr. Ledon again for another seven weeks.

Plaintiff next saw Dr. Ledon on March 1, 2001. He reported less diarrhea, no bleeding, soreness in his knees, and face swelling. He was also having trouble sleeping at night, and sometimes felt nervous. At that time, plaintiff was taking Metronidazole, Asacol, and prednisone, thirty milligrams daily. Dr. Ledon found the face and knee swelling to be normal side effects of prednisone, even on a low dose.

He tapered the prednisone by five milligrams, and continued to taper in five-milligram increments until it reached a total of five milligrams every other day. He did not order any blood work because plaintiff "was already down to 30, and I knew that before on 40, he had no problems. The blood work would have made sense at 60 after 2 weeks, but not then. I want blood work later on, not then." He told plaintiff to schedule a follow-up appointment in two months.

According to Dr. Ledon, doctors are reluctant to prescribe steroids because of their side effects. He decided to prescribe it here because, at the time, no other medication would put a patient with moderate or severe ulcerative colitis into remission. The side effects are serious. In addition to rare cases of aseptic necrosis,*fn5 "almost all patients gain weight, develop acne, [and] their blood pressure will increase." Steroids also cause faces to swell. For these reasons, gastroenterologists use steroids to treat ulcerative colitis "for a very short period of time."

After the disease goes into remission, Dr. Ledon would switch to other medications that did not have these side effects. Dr. Ledon testified, however, that all medications used to treat ulcerative colitis and Crohn's disease (another IBD) could be potentially fatal. In his thirteen years of practice, he treated, on average, eight to twenty patients a week for IBD; none of his other patients have developed avascular necrosis.

When plaintiff next saw Dr. Ledon on May 4, 2001, he was taking five milligrams of prednisone, along with Asacol and Percocet for pain due to a kidney stone. He reported feeling well, with no problems. Dr. Ledon did not want him to stay on the steroids because he had had a flare up when he stopped taking prednisone the month before his first visit, and another flare up when he was on Asacol. Dr. Ledon thus decided to start plaintiff on an immunosuppressant called 6-Mercaptopurine ("6-MP") or Purinethol.

Because Purinethol takes between twelve and sixteen weeks to work, Dr. Ledon decided not to take plaintiff completely off the prednisone. It was also his practice to inform his patients about the complications of Purinethol, which include acute pancreatitis. In this light, he planned to do blood work in four weeks after the drug would have the maximum effect on plaintiff's bone marrow. Four weeks later showed plaintiff in good health; blood studies indicated that the red cells were slightly decreased, but the white count was not seriously affected.

On October 6, 2001, plaintiff went to Colombia; he returned three weeks later on October 27, 2001. During that time, he saw a person he described as an "herbal doctor." He brought natural medicines back to the United States with him. Sometime before his next visit, plaintiff's wife went to see Dr. Ledon. She told him that she was worried for her husband because he was drinking alcoholic beverages and was not taking his medications.

Plaintiff returned to Dr. Ledon on January 17, 2002, eight months after his last visit. He complained that the medicines made him nervous, bloated, and unable to sleep, and that he had headaches and dizziness. He did not mention any bone or joint pain. At that time, he was taking only the natural medicines he had brought back from Colombia; he did not show these "medicines" to Dr. Ledon, however. Dr. Ledon described plaintiff's physical appearance as cushingoid or "moon faced."

He prescribed a new 5-ASA compound called Colazal and another steroid called Entocort EC. He decided not to prescribe prednisone, and reminded plaintiff of the importance of maintaining the medication regimen prescribed.

Plaintiff returned on April 10, 2002 complaining of dizziness, severe abdominal pain, diarrhea, and bleeding. He was taking only Colazal. Dr. Ledon increased the dosage of Colazal, prescribed forty ...

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