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June 15, 2012-Lessons Learned from Centocor v Hamilton and the Learned Intermediary Doctrine




Lessons Learned from Centocor v Hamiltonl and the
Learned Intermediary Doctrine


By Deborah E. Lewis

It is not new that Texas courts have applied the learned intermediary doctrine in prescription drug cases, nor is it new that some Texas courts have found an exception to the learned intermediary doctrine when a patient consumed/received a prescription drug outside of the physician patient relationship. What is new is that the Texas Supreme Court not only directly addressed the applicability of the learned intermediary doctrine in the context of a patient physician relationship, but it also refused to recognize a new exception to the doctrine. That new exception — direct-to-consumer advertising — was rejected under the specific facts of the case. The Court concluded there was no causal link between any direct advertising and the plaintiff's alleged harm because the plaintiff watched a video about the drug after her physician prescribed it and after its administration had already begun. Based on these facts, the Court reasoned, there was no rationale to adopt and recognize such an exception.

The Centocor opinion contains many interesting facts and holdings, particularly for those who defend prescription drug manufacturers and physicians, and we can learn a thing or two from this case.


Lesson 1: The Battle is Not Over

Centocor does not settle the question whether direct-to-consumer advertising is an exception to the learned intermediary doctrine. To the contrary, rather than completely rejecting the direct-to-consumer advertising exception, the Court made clear that its ruling against the adoption of a new exception was limited to the case facts. In reality, the Centocor facts may be the exception rather than the norm.

In Centocor, Plaintiff, with a history of Crohn's disease, consulted with her physician about treatment, including the use of Remicade. Remicade's manufacturer, Centocor, prepared an informational video about Remicade and its administration and side effects, among other things. Before watching the informational video, Plaintiff's physician had already ordered the drug, and Plaintiff was actually undergoing administration of the drug. Plaintiff ultimately developed symptoms consistent with lupus-like syndrome. Although the package insert warned about lupus-like syndrome as a rare occurrence, the informational video did not. Plaintiff argued that Centocor misled her and her physicians about the probability that she could develop drug- induced lupus-like syndrome.

The Court declined to adopt the direct-to-consumer advertising exception to the learned intermediary doctrine because, among other things, Plaintiff viewed the video that allegedly contained inadequate warnings after the physician had prescribed the drug and after the drug's administration had begun. Id. at *17. The likelihood of other failure to warn cases having similar facts seems nil. Thus, some will argue that this holding can be distinguished, and Texas should adopt the direct-to-consumer advertising exception where the evidence establishes a drug manufacturer's direct advertising to a patient before the prescribing physician chooses the drug.

Because the Texas Supreme Court also stated that "[it] acknowledge[d] that some situations may require exceptions to the learned intermediary doctrine," it is almost certain that we will continue to litigate the direct­to-consumer advertising exception. Instead of formality, or at least some certainty, under Texas law, plaintiffs will continue to bring failure to warn claims against drug manufacturers who provide patient informational videos or other advertising materials about a drug that reach the public.

Lesson 2: A Plaintiff Cannot Plead Around Learned Intermediary Doctrine

It may not matter what nuanced theories a plaintiff alleges if all of the claims turn on the manufacturer’s duty to warn. Plaintiff brought claims against Centocor for strict liability, negligence, gross negligence, fraud, misrepresentation and malice. At the time of jury submission, Plaintiff dropped strict liability and submitted negligent misbranding, negligent marketing, negligent undertaking, misrepresentation and fraud. Id. at *8. Yet, Centocor successfully argued that all of Plaintiff’s claims were premised on a single failure to warn cause of action and only a failure to warn theory should have been submitted to the jury. Id. Agreeing with Centocor, the Court held that a plaintiff could not plead around the basic requirements of a failure to warn claim when the crux of the claims rested on the drug manufacturer’s alleged failure to provide an adequate warning of the potential risks of the drug. Id. at *23. The learned intermediary doctrine applied to all of Plaintiff’s claims.

Lesson 3: A Non-Prescribing Physician Has No Duty to Warn. Probably.

Another interesting fact in Centocor is that Plaintiff viewed the informational video and the drug was administered at an intravenous infusion clinic. Plaintiff alleged that the non-prescribing physician at the clinic also had a duty to warn of the drug’s potential risks because Centocor transferred its duty to warn to the nonprescribing physician when it sent him the informational video. Id. at *20. It should not be a surprise that the Court sided with the appellate court and found that the non-prescribing physician had no duty to warn Plaintiff of all the possible risks of a drug the physician did not prescribe. Id. at *20-21. After all, the foundation of our healthcare system starts with the physician-patient relationship, including the ultimate decision for treatment that rests with the prescribing physician. Id. Necessarily, the duty to warn a patient of potential risks of a drug belongs to the prescribing physician who makes the decision to use the drug along with the patient. Id. The non-prescribing physician should not have to second-guess the professional judgment of the prescribing physician, and the Court refused to carve out a “shared intermediary” duty to warn. Id.

What may be a surprise is that the Court, again, left open the possibility of future litigation on the subject. In a footnote, the Court noted that it was not holding that the non-prescribing treating physician could never be held liable for information provided to a patient. Id. at *21. So, should we expect future plaintiffs to allege failure to warn claims against non-prescribing physicians? Probably.

Lesson 4: Still Necessary to Prove Producing Cause 

Centocor makes clear that the burden of proving “producing cause” remains with a plaintiff. Id. at *24. In this case, Plaintiff failed to prove that the allegedly inadequate warning was the producing cause of her injury because the prescribing physician did not state that he would have changed his decision to use the drug. Id. The message to plaintiffs is simple. Whether the physician would have decided not to use the drug is critical. It is not enough for a physician to admit he would want to know more about the number of cases of patients developing a disease or to admit he would consider post-approval data or additional reports of disease had they been disclosed. Such evidence constitutes “no evidence” of producing cause according to the Centocor opinion. Id. at *24-26.

For defense counsel, the message is equally clear. Even though a package insert contains the actual malady about which a plaintiff complains, as the package insert did in Centocor, expect the argument to be that the 2 The applicability of Tex. Civ. Prac. & Rem. Code, §82.007(b)(1) was not an issue in Centocor. The Fifth Circuit has recently held that §82.007(b)(1) is preempted by federal law pursuant to Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). See Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012). “risk probability” was not adequately disclosed. Notwithstanding these novel twists on what makes a warning inadequate, counsel must continue to vigorously prepare for and present evidence that the prescribing physician knew the risk and would have still prescribed the drug even if the warning had contained additional information. With such evidence, a court may likely rule that, as a matter of law, any alleged inadequacy of the drug’s warning is not the producing cause of injury. Id. at *23.

Lesson 5: Learned Intermediary Doctrine is Not an Affirmative Defense

The Court ruled that the learned intermediary doctrine is not an affirmative defense, thus the burden remains with a plaintiff to prove an inadequate warning. Id. at *20. In conclusion, even though knowledge that prescription drugs have possible risks of side effects is ubiquitous and always has been in our society, we continue to see more and more lawsuits against drug manufacturers for complaints about side effects, even when those side effects are non-life threatening and the drug effectively treated the disease. The Texas Supreme Court could have, but did not, foreclose the possibility of further litigation on the direct-to-consumer advertising exception to the learned intermediary doctrine. Consequently, prescription drug manufacturers may still face uncertainty in Texas courts when it comes to a legal challenge over its product labeling and marketing. Hopefully at some point in the future, the number of lawsuits alleging failure to warn of drug side effects, particularly non-life threatening side effects, will wane.


 1   Centocor, Inc. v. Hamilton, --S.W.3d--, 2012 WL 2052783 (Tex. June 8, 2012) 
For further information, please contact Deborah E. Lewis at (214) 665-4157 or
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