Centocor, Inc. v. Hamilton

CENTOCOR, INC., PETITIONER,

v.PATRICIA AND THOMAS HAMILTON,RESPONDENTS AND CROSS-PETITIONERS,

v.MICHAEL G. BULLEN, M.D.,

CROSS-RESPONDENT

No. 10-0223

SUPREME COURT OF TEXAS

OPINION DELIVERED: June 8, 2012

ON PETITION FOR REVIEW FROM THE

COURT OF APPEALS FOR THE THIRTEENTH DISTRICT OF TEXAS

Argued December 8, 2011

JUSTICE GREEN delivered the opinion of the Court.

Under the learned intermediary doctrine, the manufacturer of a pharmaceutical product satisfies its duty to warn the end user of its product's potential risks by providing an adequate warning to a "learned intermediary," who then assumes the duty to pass on the necessary warnings to the end user. See, e.g., Gravis v. Parke-Davis & Co., 502 S.W.2d 863, 870 (Tex. Civ. App.—Corpus Christi 1973, writ ref'd n.r.e.). In this case, we consider the applicability of thelearned intermediary doctrine to a patient's claims against a prescription drug manufacturer, whose product allegedly caused a serious injury. We hold that the doctrine generally applies within the context of a physician-patient relationship and allows a prescription drug manufacturer to fulfill its duty to warn end users of its product's potential risks by providing an adequate warning to the prescribing physician. We further hold that the court of appeals erred by creating an exception to the learned intermediary doctrine for direct-to-consumer (DTC) advertising. Although the patient alleged various common law causes of action, all of the patient's claims turn on the prescription drug manufacturer's failure to warn. Therefore, the learned intermediary doctrine applies to all of the patient's claims, and the patient was required to show that an inadequate warning to the prescribing physicians caused the patient's injuries. Because the patient presented no evidence that the allegedly inadequate warning was a producing cause of her physicians' decisions to prescribe the prescription drug, her claims fail as a matter of law. Accordingly, we reverse the court of appeals' judgment in part and render judgment that the plaintiffs take nothing.

I. Background

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.¹ In August 2006, the Hamiltons amended their claims andadded Patricia's prescribing and treating physicians as defendants. They claimed that Centocor was liable for, among other things, (1) "manufacturing, promoting, distributing and/or selling Remicade®," which was "defective and unreasonably dangerous" because of "inadequate and inappropriate warnings and instructions for use"; (2) negligence; (3) gross negligence; (4) fraud; and (5) malice. The Hamiltons claimed that Remicade caused Patricia to suffer a serious drug-induced side effect called lupus-like syndrome. The Hamiltons also alleged that Patricia's medical providers failed to adequately warn Patricia of the risks associated with Remicade and failed to obtain her informed consent to the treatment.

In the course of her prescribed treatments, Patricia's treating physician, Michael Bullen, M.D., showed her an informational video that he received from Centocor. The Hamiltons alleged that Centocor'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 Centocor to warn Patricia directly of Remicade's potential risks and side effects, thereby making Centocor liable for Patricia's injuries. The jury found in favor of the Hamiltons, 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 Centocor's actions caused Patricia's injuries.

A. Patricia's Medical History Prior to 2001

Patricia Hamilton has a complicated medical history. For more than two decades, she has suffered from Crohn's disease, recurring joint pain, arthritis, and several other ailments. Crohn's disease is a chronic, lifelong inflammatory condition that can affect any part of the digestive system. There is no cure for the disease; however, patients have several treatment options, which seek to control intestinal inflammation. Over the years, Patricia underwent various procedures to treat the disease and mitigate its effects. By 2001, Patricia 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—Patricia contracted hepatitis C from a blood transfusion. She was also diagnosed with sarcoidosis.²

B. Dr. Hauptman Treats Patricia's Crohn's Disease

In September 2001, Patricia experienced a "flare" in her Crohn's disease and sought treatment from Ronald Hauptman, M.D., a gastroenterologist who was practicing in Corpus Christi. To confirm that Patricia's symptoms were caused by her Crohn's disease, Dr. Hauptman tracked Patricia's reported abdominal pains for several weeks and ordered a series of tests, including a CAT scan and an upper GI.³ By December 2001, Dr. Hauptman confirmed that Patricia was experiencing a moderate flare in her Crohn's disease.

Dr. Hautpman testified that it was important to treat the Crohn's flare quickly to mitigate the risk that Patricia would lose more of her bowels. 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, Dr. Hauptman testified that 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.

C. Remicade

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.⁴ An immunomodulator medication, Remicade is designed to suppress the immune system's inflammatory response to the affected bowel. Patients receive Remicade treatments through intravenous infusions—the medication is injected through an IV catheter in the patient's arm.

1. The FDA Approval Process

Barbara Matthews, M.D., an FDA administrator from 1994 to 2000, testified as an expert on the FDA approval process. Dr. Matthews was the clinical reviewer of Centocor's application forFDA approval of Remicade and testified about her knowledge of the drug and her review of the safety and clinical data supporting Centocor's application. According to Dr. Matthews, once the FDA approves a drug for prescription use, the drug manufacturer drafts a package insert, which contains the clinical information, warnings, and other information known about the drug. The FDA then reviews the proposed package insert, makes revisions, and ultimately approves the insert for distribution with the drug. According to Dr. Matthews, the purpose of a package insert

is to describe both the safety and efficacy that were reported to [the] FDA and . . . provide[] information to the physician regarding the types of events, the serious[] nature of some of the events, the incidents of the events and, yes, the physician uses [this information to assess the] risk to the patient when they prescribe the medication.

. . . .

The degree of risk to the individual patient really depends on the physician's knowledge of the patient and then also the information that's in the label but the label really doesn't link directly that patient to the degree of risk.

Additionally, once a drug has received FDA approval, the manufacturer must submit periodic safety update reports to the FDA. These post-approval reports contain cumulative summaries of the drug's safety information, including updated clinical studies and any other medical findings published about the drug. Depending on the number, nature, and severity of events reported for a given adverse reaction, the FDA may recommend that the manufacturer (1) continue to monitor the events, (2) change the warning label, or (3) conduct additional studies. Because the FDA requires continuing studies of the safety and efficacy of the prescription drug, it is common for the package insert to undergo revisions as new information becomes available.

2. The 2001 Remicade Package Insert

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:

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 discontinued (see ADVERSE REACTIONS, Autoantibodies/Lupus-like Syndrome).

. . . .

ADVERSE REACTIONS:

A total of 771 patients were treated with REMICADE in clinical studies. In both rheumatoid arthritis and Crohn's disease studies,

...