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A recent Supreme Court of Texas ruling on drug safety liability, citing 'learned intermediary doctrine' leaves physicians open to litigation and patients out in the cold.

By Anonymous on Jul 17, 2012

Recently, the Texas Supreme Court ruling of Centocor Inc., v. Patricia and Thomas Hamilton broadly stated that “a prescription drug manufacturer fulfils its duty to warn end users of its product’s risks by providing adequate warnings to the intermediaries who prescribe the drug and, once fulfilled, it has no further duty to warn the end users directly.”

The decision means that immunity for the drug manufacturer was available, irrespective of direct advertising to the consumer, as the patient only watched the informational pharma video after receiving drug advice from her physician. As long as drug companies send doctors the initial paperwork about the drug, they need not worry about informing patients directly. Liability is shifted to a prescribing physician who will take full responsibility for any bad or insufficient advice.

Further more, Texas patients will have to prove two facts in order to hold pharmaceutical companies accountable for the drugs they produce. Firstly, that the drug manufacturer gave the doctor misleading or insufficient information. Secondly, they were injured from the doctor’s reliance on this information. In practice, this objective information would be difficult for US patients to source, especially since every claim is a subjective one.

Unfortunately, this Texas ruling is now in line with many other US jurisdictions that impose similar evidence hurdles for failure-to-warn claims. It is said that this is a victory for drug manufacturers who can now concentrate more to research and developing life-saving medicines. However, in the long-run, why would patients want to purchase innovative treatments if they are not educated about its risks and side-effects? This decision will only result in poor care, a reduced amount of information and less accountability to patients.

What can be done next to ensure the right safety standards for patients? Perhaps, the FDA could change the broad ‘learned intermediary doctrine’ which fails to take account of the rise in direct-to-consumer advertising. The doctrine was developed before its rise and so does not appreciate the dangers of this type of advertising. In addition, the current FDA safety rules are already under question following the recent approval of lorcaserin, a diet drug which has raised some serious concerns of increased valve disease risks in patients. A uniform set of coherent guidelines for all US states to favour patients and drug manufacturers’ needs to be developed for courts to follow. The government needs to work together with physicians, patients and doctors to ensure that every guideline meets the needs of all concerned.

Before buying a new product, consumers have access to product information which details the possible hazards of the product. If these hazards were not clear before purchase and materialised after, consumers have a right to take legal action. In the same way, all patients should be informed of the risks of a possible drug so they can judge which treatment is right for them.

To avoid opening the floodgates to a multitude of future claims, should the government establish a clearer set of rules which all members of the healthcare community understand and approve of?