Full opinion text
OPINION Opinion by Justice YÁÑEZ. Our medical-legal jurisprudence is based on images of health care that no longer exist. At an earlier time, medical advice was received in the doctor’s office from a physician who most likely made house calls if needed. The patient usually paid a small sum of money to the doctor. Neighborhood pharmacists compounded prescribed medicines. Without being pejorative, it is safe to say that the prevailing attitude of law and medicine was that the “doctor knows best.” Pharmaceutical manufacturers never advertised their products to patients, but rather directed all sales efforts at physicians. In this comforting setting, the law created an exception to the traditional duty of manufacturers to warn consumers directly of risks associated with the product as long as they warned health-care providers of those risks. For good or ill, that has all changed. Medical services are in large measure provided by managed care organizations. Medicines are purchased in the pharmacy department of supermarkets and often paid for by third-party providers. Drug manufacturers now directly advertise products to consumers on the radio, television, the Internet, billboards on public transportation, and in magazines. Perez v. Wyeth Labs., 161 N.J. 1, 734 A.2d 1245, 1246-47 (1999) (citation omitted). Against this backdrop, we are called upon, to decide whether a drug manufacturer can rely on its adequate warnings to physicians to satisfy its duty to warn the ultimate consumer, the patient, when it directly advertises to the patient in a misleading fashion. We hold it cannot. Patricia and Thomas Hamilton sued Centocor, Inc. and others after Patricia suffered from a drug-induced lupus-like syndrome allegedly caused by her use of Remicade, a drug Centocor manufactured. Patricia was shown a video that she alleged over-emphasized the benefits of Remicade but intentionally omitted warnings about the adverse side-effects she suffered. A jury found in favor of the Hamil-tons on all issues presented. The trial court entered judgment on the jury’s verdict in Patricia’s favor for $4,687,461.70 in actual and punitive damages, and in Thomas’s favor for $120,833.71 in actual and punitive damages, based on the jury’s finding of fraud. By numerous issues, Cento-cor argues that (1) the “learned intermediary” doctrine precludes the Hamiltons’ claims because Centocor adequately warned Patricia’s physicians; (2) the Ham-iltons failed to present legally and factually sufficient evidence of causation; (3) the evidence of fraud by omission is legally and factually insufficient; (4) the Hamil-tons cannot maintain a cause of action for implied misrepresentation, and their implied misrepresentation claims fail individually; (5) the Hamiltons failed to present expert testimony on the standard of care; (6) there is no cause of action for negligent misbranding; (7) the distribution of the videotape did not constitute negligent undertaking; (8) the evidence of future damages is legally and factually insufficient; (9) Thomas cannot recover on his derivative claims; and (10) the judgment should be remitted because the trial court misapplied the punitive damages cap. Today we recognize an exception to the learned intermediary doctrine when a drug manufacturer directly advertises to its consumers in a fraudulent manner. We further hold that the causation evidence and the evidence of fraud is legally and factually sufficient to support the judgment. We hold, however, that Patricia did not present sufficient evidence of future pain and mental anguish damages. Finally, we hold that the trial court properly applied the punitive damages cap. Accordingly, we reverse the trial court’s award of future pain and mental anguish damages, modify the judgment to reflect this change, and affirm as modified. I. Background A. Crohn’s Disease and Remicade According to Patricia’s gastroenterologist, Ronald Hauptman, M.D., Crohn’s disease is an autoimmune disease that causes a chronic inflammation of the intestines. It can involve any part of the gastrointestinal tract from the mouth to the anus, but it primarily involves the distal small bowel and the colon. Crohn’s disease begins with a “flare” of inflammation that causes serious pain in the intestines, which typically increases in severity and duration. There is currently no “cure” for Crohn’s disease; however, there are several treatment options. Dr. Hauptman testified that the treatment for a patient’s Crohn’s disease depends on the severity of the disease both before and at the time of treatment. The goal of treatment is to control the intestinal inflammation. In recent medical history, steroids were the first drugs used to treat Crohn’s disease. For example, during a “flare” of the disease, prednisone is a steroid treatment that can be used to reduce inflammation. As technology advanced, drugs called “5-ASA” were developed, which are anti-inflammatory medications doctors use to maintain remission of the disease. Later, immunosuppressants were developed in an attempt to address the immune system problem and suppress the inflammatory component that attacks the bowel. Imu-ran is an immunosuppressant frequently used for this purpose. If left untreated, Crohn’s disease can cause the patient to lose the ability to digest food. A severe flare, without effective treatment, can result in a patient requiring surgery to remove inflamed portions of the bowel, which is called a “resection.” Additionally, a colostomy can be performed, where the bowel is diverted to exit the abdomen. A colostomy bag is then attached that permits the patient to pass stools into the bag, which must be drained by the patient, instead of the normal waste elimination process. Centocor is a subsidiary of Johnson & Johnson, Inc. In November 1998, Cento-cor received approval from the federal Food and Drug Administration (“FDA”) for the drug Remicade, which was approved to treat Crohn’s disease. Later, Remicade was approved to treat rheumatoid arthritis. Remicade is an immunosup-pressant. It works by binding to and blocking the harmful effects of tumor necrosis factor (“TNF”), a substance naturally produced by the body that causes inflammation. Centocor called Barbara Matthews, M.D., to testify at trial about the approval process at the FDA. Dr. Matthews worked for the FDA between 1994 and 2000 and was the clinical reviewer for Cen-tocor’s application for FDA approval of Remicade. According to Dr. Matthews, when a drug is approved, the drug manufacturer drafts what is called a “package insert,” which contains warnings and other information about the drug. The FDA reviews the proposed package insert and makes revisions. After the package insert is approved, it is typically revised over time as new information becomes available. On August 8, 2001, the Remicade package insert warned of lupus-like syndrome as follows: PRECAUTIONS: Autoimmunity Treatment with REMICADE may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with REMICADE, treatment should be dis- continued (see ADVERSE REACTIONS, Autoantibodies/Lupus-like Syndrome). ADVERSE REACTIONS: Autoantibodies/Lupus-like Syndrome In the ATTRACT rheumatoid arthritis study through week 54, 49% of REMI-CADE-treated patients developed antinuclear antibodies (ANA) between screening and last evaluation, compared to 21% of placebo-treated patients. Anti-dsDNA antibodies developed in approximately 10% of REMICADE-treat-ed patients, compared to none of the placebo-treated patients. No association was seen between REMICADE dose/schedule and development of ANA or anti-dsDNA. Of Crohn’s disease patients treated with REMICADE who were evaluated for antinuclear antibodies (ANA), 34% developed ANA between screening and last evaluation. Anti-dsDNA antibodies developed in approximately 9% of Crohn’s disease patients treated with REMICADE. The development of anti-dsDNA antibodies was not related to either the dose or duration of REMI-CADE treatment. However, baseline therapy with an immunosuppressant in Crohn’s disease patients was associated with the reduced development of anti-dsDNA antibodies (3% compared to 21% in patients not receiving any immuno-suppressant). Crohn’s disease patients were approximately 2 times more likely to develop anti-dsDNA antibodies if they were ANA positive at study entry. In clinical studies, three patients developed clinical symptoms consistent with lupus-like syndrome, two with rheumatoid arthritis and one with Crohn’s disease. All three patients improved following discontinuation of therapy and appropriate medical treatment. No cases of lupus-like reactions have been observed in up to three years of long-term follow up (see PRECAUTIONS, Autoimmunity). Dr. Matthews explained that if a risk associated with a drug’s treatment is included on the package insert, that risk is reasonably associated with the treatment. B. Evidence of Centocor’s Marketing Strategy As of June 2000, Centocor’s marketing strategy included a two-pronged approach that included educating physicians to “re-fíne their definition of the target Remicade patient” and to teach patients to “demand Remicade.” Centocor’s goal was to make Remicade “top of mind” for every rheumatoid arthritis patient. A chart admitted into evidence shows Centocor’s plan for addressing patients, and it states that the goal is to “[m]ake the consumer aware the [medical] problem is treatable” and to “[e]ncourage the patient to request a specific drug.” Centocor also required its sales associates to sell a specific number of vials of Remicade to doctors’ offices. David Dull-nig, Centocor’s local Regional Training Manager for sales, testified that as of August 2002, his goal was to “work on [doctors] being more aggressive in prescribing Remicade.” One of these strategies included encouraging doctors to provide Remicade infusions in their office to maximize the profits the doctors could realize from prescribing Remicade. Dr. Haupt-man testified that a representative from Centocor approached him to discuss the economic benefits that could be obtained because Medicare and Medicaid will pay for Remicade infusions; thus the doctors could make money from prescribing Remi-cade and providing the infusions in their offices. Centocor also attempted to minimize negative publicity about the potentially dangerous side effects of Remicade. The Hamiltons called Thomas Schiable, the vice president of medical affairs for Cento-cor, who testified about a scientific study scheduled to be published in the New England Journal of Medicine on February 13, 2003, demonstrating that problems with Remicade had been understated. Instead of addressing the substantive safety concerns raised in the article, Centocor’s “Communications Program” recognized that the New England Journal of Medicine “traditionally garners significant media attention,” which includes multiple stories filed by the Associated Press. Centocor’s stated objectives in responding to the negative article were to: (1) neutralize the commercial impact of the publication, (2) confine the story to one news cycle, and (3) provide context to the stories that appear. Furthermore, Centocor planned to “[d]e-crease/eliminate news value by pre-posi-tioning data as a ‘non-story’ with key media.” Dr. Matthews testified that it would be “highly unusual” for a drug company to undertake a program to dilute the effect of a negative peer review article. C. Drug-Induced Lupus-Like Syndrome At trial, there were numerous descriptions of “lupus-like syndrome.” Dr. Hauptman and Mary Olsen, M.D., an expert hired by Centocor but called by the Hamiltons, testified that lupus-like syndrome has characteristics similar to the autoimmune disorder systemic lupus erys-thematosus (“SLE”), but it is caused by a drug. As soon as the offending agent is removed, the symptoms go away. According to all of the doctors that testified on the subject, diagnosis of lupus-like syndrome can be difficult. They generally agreed that the symptoms of “lupus-like syndrome” include weight gain, joint pain and swelling, fatigue, unusual weakness, rash, oral ulcers, fever, leukopenia, and pericarditis. A patient with Crohn’s disease or with rheumatoid arthritis, another auto-immune disease, could present with similar symptoms, like joint pain. Laboratory tests can be conducted to check for anti-nuclear antibodies (“ANA”) and double-stranded DNA antibodies (“anti-dsDNA” or “double-stranded DNA antibodies”). Adriana Pop-Moody, M.D., testified that the ANA test is “like a screen test” for lupus, but it is not definitive. According to Atilla Ertan, M.D., the most important test for diagnosing lupus-like syndrome is the double-stranded DNA antibody test. Dr. Ertan testified that if a patient tests positive for double-stranded DNA antibodies, the test is suggestive of lupus-like syndrome. Dr. Olsen also testified that a test can be conducted for “ant-ihistone antibodies,” which would also be suggestive of a drug-induced lupus-like syndrome. Difficulties arise in diagnosing a patient on Remicade with a positive ANA test and a positive double-stranded DNA antibody test because patients receiving Remicade may test positive for these antibodies without having lupus-like syndrome. Thus, Dr. Olsen explained that to diagnose lupus-like syndrome, a doctor must look at both the laboratory test results and the clinical presentation of symptoms. According to Dr. Olsen, because a positive ANA and double-stranded DNA antibody test may be produced by the Remicade itself, a test that is positive for antihistone antibodies gets her attention and indicates lupus-like syndrome. D. Patricia’s Medical History Prior to 2001 Patricia has a complicated medical history. At the time of trial, Patricia was forty-seven years old and had suffered from Crohn’s disease for most of her life. She was finally diagnosed in 1977, when she was seventeen years old. Over the course of the disease, Patricia had undergone multiple surgeries, involving the removal of sections of her bowel, colon, and rectum; she also had a permanent colostomy. During one of the surgeries, Patricia contracted hepatitis C from a blood transfusion. Patricia also was diagnosed with sarcoido-sis. E. Ronald Hauptman, M.D. On June 1, 2000, Patricia became a patient of Dr. Hauptman, a gastroenterologist then practicing in Corpus Christi, for her Crohn’s disease. At that time, Patricia was taking various medications related to her medical conditions, including the immunosuppressant Imuran. Patricia reported to Dr. Hauptman that she was not taking any 5-ASA medications because she had an allergic reaction to those type of drugs in the past. In addition to Crohn’s disease, Patricia reported a history of bleeding from a duodenal ulcer, hepatitis C, gastroesophageal reflux disease, sarcoi-dosis, and hormonal replacement therapy. Furthermore, Patricia reported to Dr. Hauptman that she had rheumatoid arthritis. Patricia testified that prior to moving to Corpus Christi, she had seen a rheumatol-ogist in Tyler, Texas, for pain she was experiencing in her hands. The rheuma-tologist told her that “any soft tissue swelling was rheumatoid arthritis.” However, laboratory testing for rheumatoid arthritis was not conducted on Patricia at that time. Patricia explained that she reported this as part of her history to Dr. Hauptman because she did not want to leave out anything that might be important. She stated that the joint pain she experienced was not significant and that at the time she first went to Dr. Hauptman, she was not taking any medication for joint pain. Dr. Haupt-man’s notes from Patricia’s first visit state that she reported a “rheumatoid arthritis history” and stated that “her hands and hips bother her the worst.” Dr. Hauptman referred Patricia to a primary care physician, Robb Sherron, M.D., and to a respiratory therapist, identified only as Dr. Miller, for her sarcoido-sis. Dr. Miller performed lab work on June 19, 2000. At that time, Patricia tested negative for rheumatoid factor, which is the indicator for rheumatoid arthritis. Dr. Hauptman conceded that he never saw any laboratory testing that indicated that Patricia had rheumatoid arthritis. Additionally, Patricia’s chest x-ray showed no signs of sarcoidosis. During this time, Patricia’s Crohn’s disease was asymptomatic. In September 2001, Patricia’s Crohn’s disease again became symptomatic. In December 2001, after conducting diagnostic tests, Dr. Hauptman determined that Patricia was suffering a “moderate flare” of her Crohn’s disease. Based on her existing medical regimen and her reported allergic reaction to the 5-ASA category of drugs, Dr. Hauptman testified that Patricia’s only two treatment options were steroids or Remicade. Dr. Hauptman claimed that he discussed both options with Patricia. He testified that Patricia did not want to take steroids because she did not like how she felt when she took them. Although Patricia claimed that Dr. Hauptman did not offer her a course of steroids as an option, she agreed that she probably told Dr. Hauptman that she did not like steroids. Dr. Hauptman testified that he also discussed the risks of using Remicade, including the risk of developing a lupus-like syndrome. Patricia and Thomas, however, denied that Dr. Hauptman ever discussed the risk of lupus-like syndrome. Patricia testified that in December 2001, she did not know what lupus or lupus-like syndrome was, and that having that knowledge would have been important to her. Dr. Hauptman prescribed an induction series of three doses of Remicade to be administered at an infusion clinic over a six-week period from December 19, 2001, to January 30, 2002. F. The Centocor Video Dr. Hauptman referred Patricia to the infusion clinic of Michael G. Bullen, M.D., to receive the Remicade infusions. Patricia first went to the clinic on December 17, 2001, to receive a tuberculosis test, which must be performed before Remicade can be started. At that time, Polly Swinney, a nurse at the infusion clinic, took a history from Patricia. Swinney noted that Patricia reported a history of arthritis, but Patricia did not report any pain associated with the arthritis at the time she first came to the clinic. Dr. Bullen testified that because the decision to take Remicade has already been made by the time a patient arrives at his infusion clinic, he does not typically warn patients about adverse side effects, except to provide them information about reactions that might occur during the infusion process. Dr. Bullen testified that he has a computer that prints out drug information sheets. He claimed that when Patricia came to the infusion clinic on December 19, 2001, for her first infusion, he gave Patricia one of these sheets. He did not have a copy of the exact sheet that he gave Patricia, explaining that the computer is now updated with new information. However, a copy that he printed out in 2004 right before trial did not contain a warning about lupus-like syndrome. Dr. Bullen testified that he did not warn Patricia about lupus-like syndrome. Swinney stated that she does not review drug package inserts with patients, and she did not review the package insert for Remicade with Patricia at any time. Rather, she completes a “Patient Teaching Checklist,” which requires her to advice patients of only the following side effects: “headache, chills, fever, nausea, vomiting, dyspnea, vertigo, upper respiratory infections, hypertension, [and] hypotension.” Swinney testified that these side effects were expected and watched for during the infusion process itself. In addition to the checklist, Swinney showed patients a video produced by Cen-tocor. On December 19, 2001, while Patricia was receiving her first infusion, she was shown the Centocor video, which Dr. Bullen referred to as a “treatment companion” kit. Dr. Bullen testified that the purpose of the video was to show “some of the effects of the drug on certain people.... It’s very dramatic in some people.” The video was shown to the jury. It begins by showing a woman with her family (“Patient 1”). Patient 1 states that she has had this condition for a while now, and it’s stopped me from doing the everyday things that I used to do all the time. I have two children, and [it] was very hard for me to fulfill what they expected their mom to do. My quality of life was deteriorating, and I was not happy. Next, a man appears (“Patient 2”). He states: “I’ve tried several different drugs. Some were more successful than others, but none really lasted a long time.” A different woman then appears (“Patient 3”). She is shown moving about her kitchen normally, opening the refrigerator. Patient 3 claims she was “not able to do a lot of things that I would have liked to have done. I felt like my life was limited.” Patient 1 appears again and states: We couldn’t control what I had and the doctors really were trying many different medications for me. And basically things just went from bad to worse. The decision to try Remicade was made with my doctors. It was presented to me that this might help. While Patient 1 is speaking, she is shown walking normally down the street and into a building. A nurse appears and explains that the infusions can take place in a hospital or an infusion clinic. Patient 1 enters an infusion clinic and is greeted by a nurse in a friendly manner. A doctor appears, identified as Aan Saf-di, M.D., who explains that Remicade is administered by intravenous infusion. Dr. Safdi explains the infusion process, and Patient 1 begins receiving an infusion. She is smiling and looks comfortable. She says that the worst part of the procedure is inserting the needle into a vein. Dr. Safdi explains that the infusion lasts two to three hours. The three patients then take turns explaining how, during the infusion process, people sleep, eat, watch television, read, or make friends. The video paints a portrait of a relaxed atmosphere. Patient 1 explains that a doctor comes to check on her during her infusions. She states that he is checking to see if “anything immediate is happening during the infusion.” Dr. Safdi then states: Physicians should discuss with their patients all potential side effects that may occur during these infusions. There are reports of serious infections, including sepsis and tuberculosis, that may be life threatening. So if you are prone to or have a history of infections, currently have one or develop one while taking Remicade, tell your doctor right away. Aso tell your doctor before beginning treatment if you have had recent close contact with or if you have had past exposure to people with tuberculosis, or if you have any other reason to believe you may be at risk. There are also reports of serious infusion reactions like hives, difficulty breathing, and low blood pressure. If you have a demyelinating disease such as multiple sclerosis, tell your doctor before you are treated. In rare cases people with demyelinating disease who were treated with Remicade have seen their symptoms intensify. Up to one in four people experienced the following side effects in clinical studies: upper respiratory infections, headache, nausea, cough, sinusitis, or mild reactions to the infusion such as rash or itchy skin. But the vast majority of patients, in our experience, have no problems with the infusion. Dr. Safdi explains that after the infusion, patients are kept at the infusion center for thirty minutes for observation and that most people drive themselves home. Patient 2 says that after his infusions, he can do whatever he wants, like “grab something to eat. I can go back to work if I like. I can go to the park, whatever I would ordinarily have done.” The video shows Patient 1 getting up from the chair in the infusion center and leaving. Dr. Safdi then says: Ater the infusion there are very little side effects that people need to watch for. If they have any discomfort, we ask them to give us a call. But those reactions, again, are extremely rare. And the vast majority of patients really experience no side effects. The video again shows Patient 1 walking down the street. She says: I usually feel really good after the infusion and then when I get home I realize I’m tired. My husband will come home early from work and let me rest a little bit. But that’s about it. And then I start feeling better. Really better. And that’s what I look forward to. Dr. Safdi appears again and explains that patients may not have a “peak” effect for a week or two after infusion. He says that the drug is “quite effective.” A disclaimer appears on the screen that says, “RESULTS MAY VARY.” Patient 1 is shown again walking down the street and purchasing flowers, then she meets her family. She picks up her children and hugs them. Then she states, “Remicade is the drug that helped me get better. People who [sic] want to know if that’s going to make them feel better, and for me, it worked.” Patient 2 is shown getting on and off a subway train and jogging up the stairs out of the subway station. He claims, “Since I began taking the drug, the quality of my life has definitely improved.” Dr. Safdi then exclaims, “I’m extremely enthusiastic about this whole new class of drugs! We’ve helped people with disease that hasn’t responded to other forms of therapy.” Patient 3 appears in her kitchen making coffee. She states, “I would definitely tell someone to try Remicade. It’s definitely helped me.” Dr. Safdi then says, “This is a new era for medicine. This type of therapy. And it’s provided a lot of people tremendous benefit. And I wouldn’t be scared of the infusion process in and of itself.” Patient 2 is shown throwing a ball with his dog. He states, “It’s been nothing but a great success for me.” Finally, Patient 1 is shown walking down some stairs holding her children’s hands. She easily picks one of her children up. She states, “The fact that there is no cure for my condition makes it very difficult, but having a drug that’s going to give me back my quality of life is the best that we could ask for.” At the end of the video, a disclaimer rolls down the screen that says: If you have any questions after watching this video, talk to your healthcare provider. You can also visit our website at www.remicade.com for more information on REMICADE. This video should not be used as a substitute for talking with your doctor. Indications REMICADE (infliximab) is indicated for the treatment of rheumatoid arthritis and Crohn’s disease. Rheumatoid arthritis REMICADE, in combination with me-thotrexate, is indicated for reducing the signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate. Crohn’s Disease REMICADE is indicated for the reduction in signs and symptoms of Crohn’s disease in patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapies. The safety and efficacy of therapy continued beyond a single dose have not been established. REMICADE is indicated for the reduction in the number of draining enterocu-taneous fistulae in patients with fistuliz-ing Crohn’s disease. The safety and efficacy of therapy continued beyond three doses have not been studied. REMICADE should not be administered to patients with known hypersensitivity to any murine proteins or other component of the product. There are reports of serious infections, including sepsis and tuberculosis, that may be life-threatening. So, if you are prone to or have a history of infections, currently have one, or develop one while taking REMICADE, tell your doctor right away. Also tell your doctor before beginning treatment if you have had recent close contact with, or if you have had past exposure to people with tuberculosis, or if you have any other reason to believe you may be at risk. There are also reports of serious infusion reactions with hives, difficulty breathing, and low blood pressure. If you have a de-myelinating disease such as multiple sclerosis, tell your doctor before you are treated. In rare cases, people with de-myelinating disease who were treated with REMICADE have seen their symptoms intensify. Up to one in four people experienced the following side effects in clinical studies: upper respiratory infections, headache, nausea, cough, sinusitis or mild reactions to the infusion such as rash or itchy skin. (Please see the accompanying Full Prescribing Information). It is undisputed that the video did not list lupus-like syndrome as a potential side effect. Patricia said that after watching the video, she “felt very good about Remi-cade treatment.” She explained, “I thought it was going to change my life and make me feel great like all the people in the video.” Patricia stated that she did not have any concerns about taking additional infusions after watching the video and did not believe she needed to do any additional research. Thomas testified that he watched the video with Patricia at the infusion clinic. He stated that the video “didn’t really address anything about safety, but everybody seemed to be very happy to have it, on the videotape.” Swinney testified that the videotapes from Gentocor come in boxes wrapped in cellophane and that the boxes containing the videos usually come with “the video, a couple of brochures in there to tell about the drug ... and it usually comes with the package insert that comes also with the medications.” She stated that the package insert “tells all sorts of things about the medication itself: [h]ow it was manufactured, some of the testing that was done, the side effects, adverse reactions, all those sorts, and the dosing.” She testified that the “full prescribing information” refers to the package insert. Swinney admitted, however, that she opened the box and removed the videotape to show Patricia the video. Swinney claimed that after Patricia watched the video, Swinney put the video back in the box and gave Patricia the box to take home. Patricia came back to the infusion center for two more infusions of Remicade, one on January 2, 2002, and another on January 30, 2002. At some point in between the first and second infusions, Swinney gave Patricia a different Centoeor video to take to her sister, who had rheumatoid arthritis. This video was marked as Plaintiffs Exhibit 35. The box containing this video has a plastic sleeve on the inside cover that contains the package insert for Remicade. The video shown to Patricia at the infusion center, however, was marked as Plaintiffs Exhibit 34. It does not have a plastic sleeve on the inside to hold any written materials, and the box only contains the video. Swinney admitted that if any written materials were in the box, she would have had to remove them to access the video. Swinney claimed that after she showed the video to Patricia, she put the video back in the box and placed the written information on top before she shut the box. Patricia, however, testified that she was not offered any written materials along with the video. Patricia denied that the box Swinney gave her containing the video she watched had any written information in it. Patricia stated that she never opened the box again after watching the video at the infusion center, and if there was any written information provided, it would have been in the box when she gave it to her lawyer. Swinney testified that after starting the videotape, she did not review any other materials with Patricia, and she did not give her any written materials regarding the side effects of Remicade. Swinney further stated that she did not discuss the possibility of lupus-like syndrome with Patricia. Initially, Patricia had a good response to the Remicade therapy. After her first infusion, Swinney called Patricia to see how she was doing, and Patricia reported that she was already feeling better. At her second infusion, Patricia told Swinney that “she hadn’t felt better in a long time and that she [felt] like she was getting relief from her arthritis pain as well as her Crohn’s disease.” After two infusions, Dr. Hauptman performed a colonoscopy that indicated to him that Patricia’s Crohn’s disease was in remission. At her third infusion on January 30, 2002, Patricia reported to Swinney that she was still feeling much better. At that point, Patricia believed that she would only receive three Remicade infusions and would be done. It is undisputed that since receiving Remi-cade, Patricia has not had any problems related to her Crohn’s disease, which is still in remission. G. Patricia’s Decline and Treatment by Adriana Pop-Moody, M.D. Patricia explained that in March 2002, she began having “all kinds of joint pain and was having a lot of difficulties.” She testified that she had a rash all over her body, her throat hurt, and she was hurting all over. Thomas testified that Patricia was in so much pain that she could not dress herself or perform her normal functions. She went to see Dr. Sherron, her family practitioner. He ordered blood work, and Patricia then tested positive for rheumatoid factor and for ANA. Dr. Sherron referred Patricia to Dr. Pop-Moody, a rheumatologist. Patricia first visited Dr. Pop-Moody on April 3, 2002. Dr. Pop-Moody sent a letter to Dr. Sherron after Patricia’s first visit. She summarized the appointment and her view of Patricia’s condition: Mrs. Hamilton has had Crohn’s disease since the age of 6 and for many years she had joint pains. Initially the hands were involved. She had swelling and pain then the right foot and the right hip. She did not have lots of functional limitation and lots of discomfort in the joints[,] and they all got better when she was having the treatment done for Crohn’s with steroids or Imuran. In December and January she received the Remicade treatment. She received three doses. The first and second doses were two weeks apart[,] and the third was one month apart[,] and the Crohn’s symptoms improved dramatically along with the joint symptoms. Approximately eight weeks after the last dose of Remicade she had a big flare-up of joint pains[,] and new joints are involved this time. The hands and the right foot are very inflamed, very painful[,] but now she has shoulder pain with diminished range of motion, ankle pain and swelling, wrist and neck pain, thoracic pain[,] and also low back pain. She reached the point that she could hardly use her hands. Also, she cannot dress herself, not having enough range of motion in the shoulders. Dr. Pop-Moody testified that Patricia told her that the three doses of Remicade had dramatically alleviated her arthritis pain, but in the two months since her last treatment, she had experienced a “flare” of arthritis pain. Dr. Pop-Moody prescribed a low dosage of prednisone, which is a steroid. She also prescribed further infusions of Remicade. Patricia testified that, at that point, she believed that she had developed rheumatoid arthritis and would be on Remicade for the rest of her life. At Dr. Pop-Moody’s direction, Patricia received an infusion of Remicade on April 10, 2002. Patricia testified that when she received a Remicade infusion, she would have a period of relief where she could resume her normal activities. After the infusion in April, Patricia misunderstood that she was supposed to slowly taper-off her prednisone, and she stopped the medication too early. She suffered a severe flare of arthritis starting on May 12, 2002. Her pain was so bad that she could not sleep, could barely walk, and could barely get in and out of cars. Dr. Pop-Moody prescribed prednisone again, and Patricia got slightly better. Patricia’s second infusion of Remicade under Pop-Moody’s care was on May 23, 2002. When she saw Dr. Pop-Moody on June 27, 2002, Dr. Pop-Moody observed that Patricia was doing “better on Remi-cade,” but for the week prior to the visit, Patricia’s hands had become stiff and painful with some loss of grip strength. Dr. Pop-Moody testified that she conducted lab work, and Patricia was positive for ANA. Dr. Pop-Moody explained that she was not concerned with lupus-like syndrome at this point: Everybody has the perception- — and doctors, lots of doctors, if you have positive — are positive ANA, hey, I might have lupus.... And also, it’s not only that, there is another test which is more specific for lupus. So the ANA test, it’s like a screen test for lupus, and if you have a positive and you have no symptoms, because there are very good criteria to diagnose lupus, then you’re gonna go further down, and they’re trying to see if you have any other antibodies, auto, — we call it “autoantibodies” of immunity, — autoantibodies, which could suggest that you have a connect tissue disease, and lupus is number one. Now, what is very particular for all these medications, for the Remicade and for Imu-ran and Humira, all of them, they are— they have a degree of immunogenicity, as he mention [sic], many times. And you are gonna have this test positive, too. 17 — I think the number went a little bit higher, because now they see more and more, about 19 percent of patients who are on this medication are gonna have this positive test for lupus. Now when we go to double-stranded DNA, because I did that, too, she had— but it had no significance. 20 percent of these patients are gonna have a positive and we are gonna just watch and see what’s happening. But, you know, as we mentioned, we knew that the lupus-like syndrome is very rare, but you get prepared for it. You get your stuff there and you watch it, because this is what you need to do. At that point, Dr. Pop-Moody planned to begin weaning Patricia off of her predni-sone and to continue giving her Remicade treatments every two months. Patricia had a third Remicade infusion under Dr. Pop-Moody’s care on July 10, 2002. She finished taking prednisone on July 28, 2002. Dr. Pop-Moody saw her again on August 9, 2002. Dr. Pop-Moody testified that after stopping the predni-sone, Patricia started experiencing more pain in her shoulders, elbows, wrists, and hands. Dr. Pop-Moody’s notes indicate that Patricia was “very stiff in the morning and pretty uncomfortable[,] and at night she has problems sleeping due to the pain.” Her notes also indicate that “[t]he labs done on 6/27 showed a positive ANA and anti-[ds]DNA was also positive at 35. She had normal complements and the ENA screen was within normal limits.” Her notes state that Patricia had “[p]osi-tive serology for SLE.” Dr. Pop-Moody explained that these test results were not enough to diagnose Patricia with lupus-like syndrome because according to her, twenty percent of patients on Remicade will test positive for ANA and double-stranded DNA antibodies. Dr. Pop-Moody prescribed a shot of kenalog instead of prednisone and decided to continue Remicade treatments every two months. Patricia had another Remicade infusion on August 28, 2002, and she saw Dr. Pop-Moody on September 20, 2002. Dr. Pop-Moody testified Patricia had an “excellent response” to this treatment, but by the time another treatment was due, Patricia was again experiencing pain. Dr. Pop-Moody testified that at that time, she did not foresee Patricia ever being able to stop treatment with Remicade. Patricia’s fifth Remicade infusion prescribed by Dr. Pop-Moody was on October 14, 2002. At an office visit on November 15, 2002, Patricia reported that she was experiencing a “flare of arthritis all over for the last ten days.” Patricia told Dr. Pop-Moody that the Remicade enabled her to function fully and normally, but it was only effective in controlling her arthritis pain for a few weeks following each treatment. At that time she was experiencing neck pain, shoulder pain, and wrist and hand pain with swelling. Her hips, knees, ankles, and feet were very painful and stiff. At this point, Dr. Pop-Moody decided to increase the dose of Remicade and decrease the interval between infusions. Her notes indicate that she believed that Patricia “functions very well with this medication[,] and it is worth it to change the schedule of administration.” Patricia’s sixth Remicade infusion under Dr. Pop-Moody’s care was on November 25, 2002, and her seventh infusion was on January 9, 2003. At an office visit on January 17, 2003, Patricia’s joint pain had improved. However, Patricia reported that she had an upper respiratory infection in the first part of January involving a cough, fever, chest pressure, and another flare of joint pain. She had been admitted to the emergency room and was diagnosed with pericarditis. Patricia reported that after receiving Remicade on January 9, her joint pain was much improved, and she generally felt better. Dr. Pop-Moody’s notes indicate that she believed the “[ajcute pericarditis [was] most likely viral in nature. There is a possibility of an autoimmune pericarditis as well.” Dr. Pop-Moody decided to continue the Remi-cade infusions. Dr. Pop-Moody saw Patricia again on January 24, 2003. At this time, Patricia reported feeling fatigued and was experiencing more shortness of breath than previously. Dr. Pop-Moody noted that an echocardiogram was performed that showed a small pericardial effusion. Patricia had suffered weight loss of twelve pounds. In her assessment, Dr. Pop-Moody noted that the pericarditis was “most likely viral in nature but in the presence of diagnosis of sarcoidosis[,] a flare-up of this condition should be considered too even though the patient received immunosuppression and also the Remicade treatment.” Dr. Pop-Moody again prescribed prednisone, and she saw Patricia again on January 31, 2002, to monitor her prednisone use. On February 20, 2003, Patricia had an eighth infusion of Remicade prescribed by Dr. Pop-Moody. On March 27, 2003, Patricia called Dr. Pop-Moody’s office to report that she was running a high fever and had pain all over her body. At an office visit on April 4, 2003, Patricia again complained of joint pain in her shoulders, neck, wrists, hands, and ankles. Patricia reported having a fever of 102 degrees and chest pain on the left side of her chest, which was exacerbated by breathing and movement. Patricia had seen Dr. Sherron on March 31, 2003, who performed an echo-cardiogram and a chest x-ray. There were no signs of pleurisy or pericarditis at that time. Dr. Pop-Moody’s assessment was that “there [was] a question between rheumatoid arthritis and enteropathic arthritis. The patient has positive serologies for rheumatoid factor[,] which makes the diagnosis of rheumatoid arthritis more likely[,] but at the same time she has inflammatory bowel disease which could present the same way too.” Additionally, Dr. Pop-Moody’s notes reflected “[plositive serology for SLE which could be induced by Remieade[,] but now there are other questions about her developing clinical lupus in view of previous pericarditis and the chest pain which she had recently which are highly suggestive of pleurisy.” Dr. Pop-Moody testified that at that time, she believed that the development of lupus-like syndrome associated with Remi-cade was an extremely rare situation, and it was “[l]ow on the differential.” She stated that based on the package insert’s description of only three cases of lupus, she believed it was extremely unlikely that Patricia had lupus-like syndrome. Nevertheless, Dr. Pop-Moody’s notes indicate that she discussed the possibility of lupus-like syndrome with Patricia: I discussed with the patient all these possibilities^] and we might need to stop the Remicade at this point. Positive serology for lupus is not unusual with the Remicade[,] but developing symptoms of lupus would indicate that the patient has the condition and then the Remicade infusions won’t be so helpful. At the present moment, she doesn’t want to give up the Remicade infusion because she is feeling very well for about five to six weeks after the infusion[,] and we decided to go ahead with this infusion[,] and after that we really need to weigh the advantages or disadvantages of alpha inhibition in her case[,] and we (me and the patient) need to make a joint decision about the future of her treatment. Dr. Pop-Moody testified that she decided to run more lab work to test Patricia’s ANA levels and to look for “complements,” which she explained were important to diagnosing lupus-like syndrome. She explained that if the “complements” go down and the double-stranded DNA goes up, then she would be worried. On April 7, 2003, Patricia had a ninth infusion of Remicade under Dr. Pop-Moody’s care. Dr. Pop-Moody received a call from Patricia on April 21, 2003, and Patricia asked if she could lower her pred-nisone dosage because she was feeling better. Dr. Pop-Moody agreed, but on April 23, 2003, Patricia came to Dr. Pop-Moody complaining of pain in her chest when she took a deep breath. Dr. Pop-Moody’s notes indicate that she received the test results from the lab work she ordered earlier in April: With the last visit I repeated a rheumatoid factor!,] and surprisingly the rheumatoid factor is negative. The ANA panel showed again a positive ANA and positive double [stranded] DNA at a lower titer. This time it was 28[,] and the patient had a titer of more than 35 one year ago. Also, the complements were within normal limits. Dr. Pop-Moody’s assessment and diagnosis in her notes show that by the end of April 2003, she was seriously considering whether Patricia may have SLE or drug-induced lupus: Inflammatory arthritis most likely en-teropathic arthritis. Initially we considered rheumatoid arthritis due to the positivity of rheumatoid factor which almost excluded an enteropathic arthritis which belongs to the group of seronega-tive spondyloarthopothy which are supposed to be seronegative. Many times when we are dealing with autoimmune diseases you can see the switching of serologies with the same clinical complaints. The positivity of ANA and anti-DNA was considered up until now being induced by TNF alpha therapy but in view of the pericarditis which the patient had in the month of February, the possibility of SLE is raised. There are reports cases [sic] to develop clinical SLE meanwhile they are taking TNF alpha inhibition. I discussed with the patient extensively all of these possibilities!,] and still we do not have a firm diagnosis of lupus due to the fact that the time when she had the pericarditis she did have symptoms of an upper respiratory infection. The patient is aware of the fact that the TNF alpha therapy can induce a lupus flare which we have as an underlying condition!,] but at the present moment she does not want to stop the Remicade treatment because this stabilized her Crohn’s symptoms which were very pronounced. She had repeated surgeries done for it[,] and she does not want to return to that situation again. Also, the joint pains and stiffness are very well controlled with Remi-cade!,] and this enables her to integrate normally in her life so she is very reluctant to stop the medication especially if I do not have anything else to offer her. Consequently she is going to read more about SLE symptoms!,] and we will follow her very closely. Dr. Pop-Moody testified that she gave Patricia literature on lupus and that Patricia was going to read it. She claimed that she advised Patricia of the symptoms of lupus-like syndrome, such as rashes and “chest pains which come and go, and they hurt you when you take a deep breath.” Dr. Pop-Moody admitted that the increased joint pain that Patricia experienced could be from drug-induced lupus-like syndrome. Thomas recalled that Patricia came home from an appointment with Dr. Pop-Moody with a pamphlet on lupus, and he stated that Patricia “was supposed to go through these lupus symptoms and decide whether or not — or to decide whether or not she was having any of these symptoms. This way, they could talk about it next time they met.” Patricia testified that she recalled Dr. Pop-Moody discussing lupus with her in the Spring of 2003, although she did not specify the exact date. However, Patricia denied that Dr. Pop-Moody informed her that the Remicade could be causing drug-induced lupus; she testified that she decided to continue on Remicade because she believed, at that time, that Remicade was the only option to provide her with any relief. She testified that she did not know that Remicade was the cause of her problems at that time. Dr. Pop-Moody’s notes, however, were sent to Dr. Sherron, and in her analysis, she noted that Patricia was considering legal action against Centocor: I do not know if you are aware that she is looking for legal action against Centa-cor [sic]. The patient wants to have part of her co-pay paid by Centacor [sic] because she thinks that she started having the joint complaints so pronounced only after the Remicade was given to her. In my opinion she benefitted from Remicade extremely due to the stabilizing of her Crohn’s symptoms and also of the joint symptoms but we are in a sensitive situation and she has to take the responsibility to go ahead with this treatment as long as we have a suspicion of lupus and not to make anybody responsible in case we have more complications. I am not sure how she is going to react to these problems but I want you to be informed about all these developments. Patricia explained that “at that time my understanding was I would be on this drug indefinitely and the Remicade had actually caused the flare of rheumatoid arthritis that I was now suffering from and having to be treated with the same drug.” She believed that she would have to continue Remicade indefinitely. On May 13, 2003, Patricia had her tenth Remicade infusion, followed by another infusion on June 10, 2003. On June 27, 2003, Patricia saw Dr. Pop-Moody. Patricia reported that prior to her infusion on June 10, she experienced aches in almost all of her joints and had prolonged stiffness in the morning. Patricia also complained of shortness of breath but no chest pain. Dr. Pop-Moody testified that at that time, there was nothing indicating to her that Patricia had SLE or drug-induced lupus-like syndrome. Patricia had three more Remicade infusions on July 8, August 5, and September 2, 2003. Dr. Pop-Moody examined Patricia after her infusion on September 2. Dr. Pop-Moody noted that the August infusion only provided relief for two weeks, and then Patricia had a big flare of joint pains and swelling in the shoulders, hands, knees, hips, and feet. Dr. Pop-Moody’s notes indicate that the “joint pains are getting more and more pronounced.” They also indicate that Dr. Pop-Moody decided to stop the Remicade therapy while Patricia sought a second opinion: “We had an extensive discussion about the situation that at the present time there is no use for Remicade anymore.... I am reluctant to provide her with this medication anymore without having a second opinion.” Dr. Pop-Moody testified that by this time, Patricia’s flares of joint pain were becoming more intense, and the duration of the relief periods following each treatment was becoming shorter. Dr. Pop-Moody referred Patricia to a group of physicians at the University of Texas Health Science Center in Houston for consultation and treatment. H. The Houston Doctors On September 30, 2003, Patricia went to the University of Texas Health Science Center in Houston and saw Maureen D. Mayes, M.D.; Noranna B. Warner, M.D.; and Leslie Wilson, M.D. Thomas claimed that he first heard the term “drug-induced lupus” in Houston from Dr. Warner. Patricia testified that it was not until she went to Houston that she discovered that the Remicade was causing her problems. Dr. Mayes and Dr. Wilson wrote a letter to Dr. Pop-Moody on September 30 after seeing Patricia. The doctors made the following assessment: 1. Symmetric polyarthritis involving the hands, elbows, shoulders, knees, and feet that could be consistent with lupus (potentially drug-induced by Remicade), although the literature is limited in supportive evidence of this entity. There have been several studies showing that the presence of double stranded DNA antibodies in patients who receive Remicade is not uncommon; however, there have been limited cases of lupus-like syndrome seen with this medication. The patient, at this time, does appear to have a syndrome that could be classified a systemic lupus erysthematosus. The clinical picture is less consistent with sarcoidosis[] or arthritis associated with sarcoidosis. The clinical presentation could be consistent with enteropathic arthritis. This could be arthritis associated with hepatitis C virus. 2. Leukopenia — possibly secondary to lupus-like syndrome or a side effect of Imuran.... The doctors decided to discontinue further treatment with Remicade because Patricia apparently was no longer benefitting from it. Instead, they prescribed increased dosages of other medications Patricia had taken off and on, including prednisone. The doctors planned to follow Patricia’s serolo-gies for the next few months to monitor her “ANA, anti double stranded DNA, and anti histone level.” At a second visit on October 15, 2003, Patricia’s condition had improved. In a letter to Dr. Pop-Moody, the Houston doctors wrote: The patient presented to our clinic for evaluation of possible lupus-like syndrome which may have been induced by Remicade therapy. Upon evaluation by her rheumatologist in Corpus Christi, the patient was found to have a positive ANA and positive double-stranded DNA antibodies. Other significant history included the episode of pericarditis in January of 2003 and the presence of leu-kopenia (absolute lymphopenia). Upon initial presentation to our clinic a few weeks ago, the patient’s physical exam showed significant tenderness on internal and external rotation of both of her shoulders. There was also some swelling of the fingers, particularly in the PIP joints bilaterally. There was decreased hand grip secondary to pain. Today, the patient states that she is much improved since her previous visit. She was able to go to the zoo earlier this week and was able to walk around for approximately 4 hours without significant joint pain. She has resumed her daily activities including dressing herself and caring for herself without needing assistance from her husband. The patient states that she has no significant morning stiffness at this time. She occasionally has some pain in her shoulders and upper extremities but feels that she is much improved since her last visit. ASSESSMENT: Symmetric polyarthri-tis involving hands, shoulders, knees, feet, which is consistent with a lupus-like syndrome (potentially drug-induced by Remicade). The patient has improved on an increased dose of Imuran 150 mg daily, increased from 100 mg daily. The patient also had increased her predni-sone dose from 10 mg daily to 15 mg daily. It was undisputed that after Patricia stopped taking the Remicade, her arthritis pain improved completely. Patricia testified that, had she known that Remicade could cause lupus-like syndrome, she would have asked more questions before making a decision to take Remicade. I. Expert Testimony on Patricia’s Diagnosis Dr. Ertan testified as an expert for Cen-tocor. He reviewed the notes from the Houston doctors, and he stated that he agreed with them that Patricia appeared to have lupus-like syndrome. Additionally, Dr. Olsen was hired by Centocor to provide expert testimony, but she was called by the plaintiffs to testify as an adverse witness. Dr. Olsen testified that it was her opinion that Patricia had drug-induced lupus. She explained: In terms of diagnosing a lupus presentation, there are certain clinical criteria that are used. That includes symptoms, signs, and then there’s laboratory studies. In terms of drug-induced, obviously, it’s not only the diagnosis of lupus, but whether there was a drug pre [sic] that set it off. And then once you remove the offending drug symptoms go away. And then there can be, in addition, certain antibodies in drug-induced lupus called “antihistone antibodies” that are important. So in terms of the rationale for lupus — -I’m still flipping through my pages, here. I might have in this paragraph new features, including joint swelling, positive ANA, positive double-stranded DNA, positive antihistone antibody, leukopenia, lyphoepenia, rash, history of oral ulcers, fever and seritosis with a pericardial effusion. All of those are clinical features that could be suggestive of lupus, and antihistone antibody, specifically drug-induced lupus. There was some pleuritic chest pain. There can be serositis or pleurisy in lupus. However, she did have the complicating history of sarcoid, so one with good emphasis [would] know whether that could be sarcoid or lupus-related. But those were the rationale for that. Dr. Olsen testified that she believed Patricia’s symptoms revealed a discernible case of lupus-like syndrome in January 2003, when Patricia developed pericarditis. Dr. Olsen explained why she believed that was a determinative factor: Because prior to that, her joint complications had certainly worsened, but it was not clear-cut what that worsening was due to. Certainly, rheumatoid arthritis would have been an initial consideration, because she did have a bilateral symmetric polyarticular synovitis process, which is a classic feature for rheumatoid. Certainly, it could have been enteropathic arthritis. I find that a little less likely, because of her treatment of multiple joints. And some of the other serologic features, her blood test features, her painful ANA positivity, and [anti-]dsDNA positivity, in the study of TNF blocker use can be seen just along for the ride and not actually be pathogenic, so those features still don’t make you have to reassess the situation. But a pericardial effusion does get one’s attention to say, well, what could this be due to? Is it an infection? Is it related to the arthritis? Rarely in rheumatoid it can occur. Is it related to perhaps a drug-induced lupus? Yes, it could be seen in that. So one would have to be rethinking it at that point. Dr. Olsen testified that she believed early on, Patricia received some relief from the Remicade, but later, as the pain worsened, Dr. Olsen believed that more of the relief was coming from steroids. James Wild, M.D., Dr. Bullen’s expert witness who was called as an adverse witness by the Hamiltons, testified that a patient who receives steroids and Remicade could believe that the relief she were getting was coming from the Remicade therapy when, in fact, the Remicade was making it worse. When asked if he believed if “information to a patient who has conditions like Mrs. Hamilton had, that Remicade therapy could induce lupus, could have influenced — could influence that patient in deciding not to take the Remicade,” Dr. Wild stated, “Possible, yes.” David Trock, M.D., an expert for the Hamiltons who was called as an adverse witness by Centocor, also testified through his deposition testimony that he believed that Patricia developed “systemic lupus ... in the middle of 2002.” When asked how to distinguish systemic lupus from drug-induced lupus and whether Patricia had drug-induced lupus-like syndrome, Dr. Trock explained: Well, a few things to consider. [Patricia] did fulfill the 1982 ACR criteria for lupus in the year, certainly in early 2003. If it’s necessary to distinguish drug-induced lupus from systemic lupus there are a few things that are ordinarily done. And one of them is to determine if there’s an offending agent responsible, to withdraw it, and see what happens to the patient. And as far as I’m aware of the record, that’s what happened. So she did indeed have lupus in probably as early as mid 2002, and the notion