Centocor, Inc. v. Hamilton

Facts

P has suffered from Crohn's disease, recurring joint pain, arthritis, and several other ailments. There is no cure for the disease. Patients have several treatment options, which seek to control intestinal inflammation. By 2001, P had part of her small intestine, colon, and rectum removed, and she lived with a colostomy. During a resection surgery-a procedure to reconnect her bowels after removing damaged tissues-P contracted hepatitis C from a blood transfusion. She was also diagnosed with sarcoidosis. P sought treatment from Ronald Hauptman, M.D. Dr. Hauptman testified that P's only two options to treat the Crohn's flare were through steroids or Remicade infusions. Dr. Hauptman consulted with P about the available treatments and explained the risks and benefits of each approach. Based in part on P'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. D provided P's doctors with a package insert that warned Remicade's use could lead to certain adverse reactions. The package insert included warning information regarding a lupus-like syndrome. Dr. Hauptman prescribed three infusions of Remicade over a six-week period. As the non-prescribing, treating physician, neither Dr. Bullen nor his staff discussed with P the risks inherent in Remicade, but they informed her of the potential risks directly associated with the infusion process. After the first infusion was started. P was shown an informational video about Remicade and the treatment process, which D had provided to Dr. Bullen. The main purpose of the video was to educate patients and make them more comfortable with the infusion process. The video provides several written warnings and disclaimers at the end of the production. It instructs patients to contact their healthcare provider if they have any questions and provides a Remicade website address for further information. The video warns of various risks associated with the infusion process, advises that 'physicians should discuss with their patients all potential side effects that may occur during these infusions,' and cautions that the 'video should not be used as a substitute for talking with your doctor.' For the treatment of fistulizing Crohn's disease, the video warning states that 'the safety and efficacy of therapy continued beyond three doses have not been studied.' After listing a series of potential side effects, the warning instructs patients to 'see the accompanying Full Prescribing Information.' It is undisputed that the video did not mention lupus-like syndrome as a potential side effect of Remicade. Infusion clinic received the videotapes from Din cellophane-wrapped boxes that usually contained the video, informational brochures about Remicade, and package inserts that provided more extensive details about the drug. P denied receiving any written information about Remicade but stated that she never looked in the box that Swinney gave her or reviewed any additional written information about Remicade. It is undisputed that, since taking Remicade, Patricia's Crohn's disease has been asymptomatic. P then experienced severe arthritis-like pains in her joints. P received fourteen additional Remicade infusions. P continued to experience severe joint pain. Each treatment provided temporary relief, but the relief periods dwindled. Eventually, it was determined that P had lupus-like syndrome. New Doctors stopped Ps Remicade treatments and, instead, prescribed steroids for her joint pains. At her October 2003 follow-up appointment, P reported that she felt much better than she did at her previous visit. Ps sued D, a prescription drug manufacturer, and subsidiary of Johnson & Johnson, claiming that D 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 incurred from using the drug. P's treating physician, Michael Bullen, M.D., showed her an informational video that he received from D. Ps alleged that D's video over-emphasized the benefits of Remicade and intentionally omitted warnings about the potential side effect of lupus-like syndrome. They argued that the video bypassed the physician-patient relationship and required D to warn P directly of Remicade's potential risks and side effects, thereby making D liable for P's injuries. D repeatedly raised the learned intermediary doctrine, contesting its duty to warn P directly. The jury found in favor of Ps, and the trial court entered judgment for approximately $4.6 million. The jury found in favor of Ps, and the trial court entered judgment for approximately $4.6 million. The court of appeals reversed the award of future pain and mental anguish damages but affirmed the remainder of the trial court's judgment, adopted a DTC advertising exception to the learned intermediary doctrine and held that the record contained sufficient expert evidence to prove that D's actions caused P's injuries. D appealed. The court of appeals adopted 'an exception to the learned intermediary doctrine when a drug manufacturer directly advertises to its consumers in a fraudulent manner.' It held that D cannot rely on its adequate warnings to P's physicians when it directly misrepresented its product's dangerous propensities to P.' D appealed. 

Issues

Rule of Law

Holding and Decision

Legal Analysis

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