June 8, 2012

Texas high court agrees with PLF to protect the rights of medicine-makers

By Texas high court agrees with PLF to protect the rights of medicine-makers

The Texas Supreme Court issued its decision today in Centocor v. Hamilton, a case in which PLF filed this friend of the court brief in defense of medicine-maker Centocor, Inc. The case involved a legal doctrine called the “learned intermediary doctrine,” which says that when a consumer buys a product on the advice of an expert, the manufacturer of that product is usually not responsible for failing to directly provide the consumer with information about that product. In other words, the drug maker is supposed to give the doctor the information about the side-effects of the medicine, and the doctor is supposed to then give the patient advice.

In this case, the patient contracted a disease after taking a drug her doctor prescribed, and then sued the manufacturer, arguing that it should have warned her about the danger of contracting the disease. Although the “learned intermediary doctrine” would normally say that it was her doctor’s responsibility to give her the warnings, she argued that the court should dispense with that doctrine. PLF’s brief argued in its defense, pointing out that it “retains validity even in this era of direct-to-consumer marketing because it is premised on the physician’s greater expertise, which has remained constant over time. Patients, too, may be more informed via their own investigations on web sites and other patient-oriented information centers, but it would be the rare patient who is as well-informed as her physician when it comes to treatment options, the effects and interactions of different drugs, and the relative risks and trade-offs inherent in choosing one treatment over another.” Worse, abolishing the doctrine would increase the costs of medical care, and would probably threaten patients’ health, because drug companies would be forced to provide unnecessary and expensive warnings. As the Fourth Circuit Court of Appeals put it, “[i]f pharmaceutical companies were required to warn of every suspected risk that could possibly attend the use of a drug, the consuming public would be so barraged with warnings that it would undermine the effectiveness of these warnings.” Doctors, too, would be unable to judge what risks are significant and what are not.

The Texas Supreme Court agreed, ruling that the “learned intermediary doctrine” remains a valid part of that state’s law. “the bedrock of our healthcare system is the physician-patient relationship, and the ultimate decision for any treatment rests with the prescribing physician and the patient. As a matter of both necessity and practicality, the duty to warn the patient of the potential risks and possible alternatives to any prescribed course of action rests with the prescribing physician.”

It’s crucial for the survival and flourishing of America’s medical industry that the makers of life-saving medicines be protected by laws that, while ensuring that they pay the price for actual wrong-doing, allow them every right to defend themselves and do not impose heavy, unnecessary costs on them. The Texas Supreme Court made the right call for the law and for Texans who depend on medicine manufacturers for their well-being.

Thanks, by the way, to attorney Kathleen Cassidy Goodman, one of PLF’s many lawyer friends who acted as local counsel for us in this case. PLF often depends on attorneys to help us file briefs in courts across the country. If you’re an attorney and would like to help us in our mission, please let us know.

What to read next