CENTOCOR, INC. v. Hamilton

310 S.W.3d 476, 2010 Tex. App. LEXIS 1623, 2010 WL 744212
CourtCourt of Appeals of Texas
DecidedMarch 4, 2010
Docket13-07-00301-CV
StatusPublished
Cited by7 cases

This text of 310 S.W.3d 476 (CENTOCOR, INC. v. Hamilton) is published on Counsel Stack Legal Research, covering Court of Appeals of Texas primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
CENTOCOR, INC. v. Hamilton, 310 S.W.3d 476, 2010 Tex. App. LEXIS 1623, 2010 WL 744212 (Tex. Ct. App. 2010).

Opinion

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 intermedi *481 ary” 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. 1 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 *482 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.

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Related

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Centocor, Inc. v. Hamilton
372 S.W.3d 140 (Texas Supreme Court, 2012)
Murthy v. Abbott Laboratories
847 F. Supp. 2d 958 (S.D. Texas, 2012)

Cite This Page — Counsel Stack

Bluebook (online)
310 S.W.3d 476, 2010 Tex. App. LEXIS 1623, 2010 WL 744212, Counsel Stack Legal Research, https://law.counselstack.com/opinion/centocor-inc-v-hamilton-texapp-2010.