Texas-sized change in the learned intermediary doctrine?

In Texas, they say everything is big. Big cars, big steaks, big football stadiums. Sounds like my kinda place. In a recent decision by the Thirteenth Court of Appeals in Corpus Christi, the jurisprudence was similarly Texas-sized, with a 35 page opinion in which the court carved out an exception to the learned intermediary defense. Centocor, Inc. v. Hamilton, No. 13-07-00301-CV, 2010 WL 744212 (Tex. App. – Corpus Christi March 4, 2010, no pet h.). Authored by Justice Linda Reyna Yanez, and joined by Justices Nelda V. Rodriguez and Rose Vela, the opinion creates an unfortunate Texas-sized exception to the learned intermediary doctrine.

In beginning its commentary on the doctrine, the Texas court looked outside of its own state and turned to, of all things, a decade old opinion from the New Jersey Supreme Court.

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., 734 A.2d 1245, 1246-1247 (N.J. 1999) (citation omitted).

The Centocor, Inc. court then framed the issue as being “…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.” Centocor Inc. at *1. The facts of the case were that the Plaintiff was prescribed Remicade by her gastroenterologist for treatment of her Crohn’s disease. Id. at *6. The prescribing physician testified that he discussed the risks of using Remicade with the Plaintiff, including the risk of developing a lupus-like syndrome. Id. The Plaintiff and her husband denied that her gastroenterologist (Dr. Hauptman) discussed this particular risk with her. Id. Dr. Hauptman referred the Plaintiff to an infusion clinic for the administration of a trial of Remicade (three intravenous infusions over a set period of time). Id. At the infusion clinic, the Plaintiff was shown a video produced by Centocor, Inc. while she was receiving her infusion. Id. at *6-10. It was undisputed that the video did not list lupus-like syndrome as a possible side effect. Id. at *9.

The Plaintiff ultimately began to exhibit lupus-like syndrome symptoms. Interestingly, even after filing the lawsuit, she continued to receive Remicade treatments. The jury awarded a verdict in the Plaintiff’s favor and found that Centocor, Inc. was liable for fraud, negligent misbranding, negligent marketing to the Plaintiff’s doctors, misrepresentation to the Plaintiff’s doctors and negligent undertaking. Id. at *19. The court performed an exhaustive analysis of the origins of the learned intermediary defense. The court also identified four “theoretical underpinnings” of the doctrine. These underpinnings include: (1) “…courts have held that the choice of which drugs to prescribe properly belongs to the doctor because prescription drugs are manufactured for administration only by a physician…” (2) “Texas courts have held that ‘only a physician would understand the propensities and dangers involved.'” (3) “…courts around the country have been reluctant to interfere with the physician-patient relationship by requiring a direct warning from the manufacturer to the patient because warnings that contradict the advice given by a physician may undermine the patient’s confidence in the physician.” and (4) “…it has been assumed that doctors are in a better position to warn their patients than the drug manufacturers…” Id. at *22-23.

The court then took a curious turn in the opinion. The court provided a discourse on “changes in pharmaceutical advertising.” Essentially, the court stated that in the 1980’s drug companies began utilizing direct marketing techniques (read “TV commercials”) that were intended to target the ultimate consumer of their products. Interestingly, the court also commented that in modern times, doctors spend less time with their patients and that “informed consent” now requires a “patient based decision rather than the paternalistic approach of the 1970’s.” Id. at*26-27. At this point in the opinion, the court stated that when drug manufacturers directly market consumers the theoretical underpinnings of the learned intermediary doctrine do not apply. Id. at *28.

In the opinion of this blogger, it appears that the Texas court made a Texas-sized mistake in interpreting the application of the doctrine. The court simply discounted the fact that the Plaintiff’s physician admitted that he discussed the specific risk of developing a lupus-like syndrome. In addition, the court seemed to overlook the fact that when the Plaintiff viewed the “direct marketing” video, she had already been prescribed the drug and was in fact undergoing an infusion of the drug at the time she viewed it. Finally, the video itself contained disclaimers that stated that the video should not be used a substitute for consulting with a physician. Id. at *9. These facts indicate that at the crucial time in which the Plaintiff obtained the prescription, she was warned about the potential risks of using the drug by a learned intermediary. In addition, at that crucial time it appears that all four of the “theoretical underpinnings” were in place and had not been compromised by any direct marketing of the drug. That is, when the Plaintiff first accepted her prescription and advice of her doctor, she hadn’t even seen the video yet. Perhaps the Texas Supreme Court will get to address this very issue in the near future.