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A prescription drug manufacturer fulfills its duty to warn end users of its product's risks by providing adequate warnings to the intermediaries who prescribe the drug and, once fulfilled, it has no further duty to warn the end users directly. But when the warning to the prescribing physician is inadequate or misleading, the prescription drug manufacturer remains liable for the injuries sustained by the patient.
For more than two decades, Patricia Hamilton has suffered from Crohn's disease, recurring joint pain, arthritis, and several other ailments. In September 2001, Patricia experienced a "flare" in her Crohn's disease and sought treatment from Ronald Hauptman, M.D., a gastroenterologist, who confirmed that it was indeed a moderate flare in her Chrohn’s disease. Based on Patricia's existing medical regimen and her reported allergic reactions to one type of anti-inflammatory medication used to treat Crohn's disease, Patricia's only two options to treat the Crohn's flare were through steroids or Remicade infusions. According to Dr. Hauptman, he consulted with Patricia about the available treatments and explained the risks and benefits of each approach. Based in part on Patricia's desire to avoid steroid treatments, which had previously caused severe adverse effects, Dr. Hauptman prescribed three treatments of Remicade, a relatively new drug that had been developed since Patricia's surgery in 1997, administered at six-week intervals of 400 milligrams each. Remicade is a prescription drug, manufactured by Centocor, that is approved by the Food and Drug Administration (FDA) for the treatment of Crohn's disease and rheumatoid arthritis. Patients receive Remicade treatments through intravenous infusions—the medication is injected through an IV catheter in the patient's arm. At the time of Patricia's initial Remicade prescription in December 2001, Centocor provided Patricia's doctors with a package insert that warned Remicade's use could lead to certain adverse reactions. The package insert included the following warning information regarding lupus-like syndrome. The package insert also included a table noting that serious adverse reactions—including systemic lupus erythematosus syndrome—occurred at frequencies of less than 2% "by body system in all patients treated with REMICADE." Dr. Hauptman then referred Patricia to Dr. Bullen for treatment. Dr. Bullen is an infectious disease specialist and, at that time, operated an infusion clinic in Corpus Christi where Patricia received the Remicade infusions. As the non-prescribing, treating physician, neither Dr. Bullen nor his staff discussed with Patricia the risks inherent in Remicade, but they informed her of the potential risks directly associated with the infusion process. At trial, Dr. Bullen did not recall confirming that Dr. Hauptman had informed Patricia of Remicade's risks. Dr. Bullen stated that he was aware that Remicade could cause lupus-like syndrome, but admitted that he probably did not give Patricia any warnings or instructions concerning the risk of developing lupus-like syndrome. After the nurse connected Patricia's IV and started the first Remicade infusion, she showed Patricia an informational video about Remicade and the treatment process, which Centocor had provided to Dr. Bullen. Patricia reported an excellent response to her Remicade treatments at Dr. Bullen's infusion clinic, and the treatments helped relieve the symptoms of her Crohn's disease. After her first two Remicade infusions, Throughout her follow-up appointments with Dr. Hauptman, Patricia reported that she was having no problems with her bowels, leading Dr. Hauptman to conclude that the Remicade treatments were successful and that Patricia's Crohn's disease remained in remission. It is undisputed that, since taking Remicade, Patricia's Crohn's disease has been asymptomatic. However, in the weeks following her initial treatments with Remicade, Patricia experienced severe arthritis-like pains in her joints. Patricia's family physician referred her to a local rheumatologist, Adriana Pop-Moody, M.D. During her initial visit with Dr. Pop-Moody, Patricia explained her recent treatments with Remicade and told Dr. Pop-Moody that it had dramatically improved her Crohn's condition and that her arthritis pains had markedly improved after her first three doses of Remicade. In April 2002, Dr. Pop-Moody prescribed treatments including additional Remicade infusions at regular intervals to treat Patricia's joint pains. Between April 2002 and September 2003, Patricia received fourteen additional Remicade infusions at the Corpus Christi Medical Center. However, Patricia continued to experience severe joint pain. Each treatment provided temporary relief, but the relief periods dwindled. In an attempt to improve Patricia's condition, Dr. Pop-Moody decreased the time between infusions and increased the dosage of Remicade. In April 2003, Dr. Pop-Moody reviewed treatment options with Patricia and discussed that she might need to stop the Remicade infusions. Dr. Pop-Moody informed Patricia that she may have lupus-like syndrome, but Patricia's medical records indicate that, despite this risk, Patricia desired to continue taking Remicade. Because of Patricia's increasing joint pain and Dr. Pop-Moody's inability to determine the cause of Patricia's continuing ailments, Dr. Pop-Moody referred Patricia to rheumatologists at the University of Texas Health Science Center in Houston who diagnosed her of a lupus-like syndrome. Within a few months of ceasing the Remicade infusions, Patricia's lupus-like symptoms subsided. Patricia's arthritic symptoms also improved dramatically after she ceased taking Remicade. In March 2003, Patricia and Thomas Hamilton sued Centocor, Inc., a prescription drug manufacturer and subsidiary of Johnson & Johnson, claiming that Centocor provided "inadequate and inappropriate warnings and instruction for use" of its prescription drug Remicade, which made Remicade "defective and unreasonably dangerous," and seeking damages for injuries that Patricia allegedly incurred from using the drug. In August 2006, the Hamiltons amended their claims and added Patricia's prescribing and treating physicians as defendants. The trial court ruled in favor of the Hamiltons and held that the learned intermediary doctrine did not preclude her recovery.
Is Centocor covered by the DTC advertising exception to the learned intermediary doctrine in its liability against Patricia?
In 1997, the Oklahoma Supreme Court recognized a marketing exception to the learned intermediary doctrine when the FDA mandated that the manufacturers, through their product labels, must communicate warnings directly to patients. Here, the alleged harm was not caused by Centocor's direct advertising to Patricia. At trial, the Hamiltons admitted that the first time they heard of Remicade was when Patricia's husband, Thomas, saw a textual banner displayed on the bottom ticker of the CNN news channel, which stated that the FDA had approved Remicade for the treatment of Crohn's disease. This innocuous news report was a far cry from the basis for the Perez court's adoption of a DTC advertising exception where the pharmaceutical company "ma[de] direct claims to consumers for the efficacy of its product" through prescription drug advertisements. Instead of DTC advertising prompting her to request Remicade from her doctors, Patricia's claims rested on the video that she viewed after her doctor had prescribed Remicade and after the infusion process had begun. Furthermore, the record indicated that this informational video was not the type of misleading DTC advertising that concerned the Perez court. According to Swinney, the nurse who remained present with Patricia during all of her Remicade treatments at Dr. Bullen's clinic, the videos were available to help patients feel more relaxed about the infusion process, by explaining some of the benefits and side effects of the treatment process. After viewing the video, Dr. Matthews testified that she considered the video to be an educational tool to help inform patients about the infusion process. And Patricia admitted that the first time she saw any literature about Remicade was when she received her first Remicade infusion at Dr. Bullen's clinic. Both Patricia and Swinney testified that Patricia was already receiving her first infusion when the video started. On this record, the rationale for adopting a DTC advertising exception to the learned intermediary doctrine was simply non-existent.