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The Washington Supreme Court in the U.S recently gave a 6 – 1 judgement on whether or not medical device manufacturers have a responsibility to warn hospitals as well as doctors and operators of the risks their products come with.
In this recent Supreme Court decision, it was held that manufacturers must also warn hospitals as the purchaser of the medical devices (and thus the consumer), as well as doctors. The lawsuit was made against Intuitive Surgical Inc. after a man died from a fatal operation involving the manufacturer’s robotic medical device. The Da Vinci system is used for minimally invasive operations whereby a doctor operates on the patient through a robotic arm controlled by an electric remote.
Although victim Fred Taylor’s widow, Josette, successfully settled with the doctor and hospital for the tragically botched operation, she also brought a lawsuit against Intuitive Surgical for not warning the consumer (the hospital) of the risks. The doctor who performed the operation admitted that Taylor had not been an optimal candidate. If the hospital had known the risks, should they be responsible for stopping the medical device from being used on a risky patient?
Washington Supreme Court thinks so.
The new precedent gives rise to various discussions:
On the other hand, all these queries may be quashed by invoking an extra step of risk assessment, and therefore making it safer for patients.
The Supreme Court based their decision on the well-established Tort principle in that the manufacturer has a duty of care to their consumer. In this case, the Hospital, as a purchaser, is the consumer. Surely if you bought something to be used by someone else, you would want to know what risks there are before passing it along. But does this logic change when the user is a medical expert who has spent years of training and in control of patient care?
The Court said:
“Hospitals cannot meet their own duty to patients without knowing the risk of the dangerous medical products they own.”
We are yet to see how the trial courts impose this in the future years. Some legal counsel have said that it won’t stick, whereas some like lead trial counsel Richard Friedman have said it will be well-established everywhere in only 20 years.
It’ll be interesting to see how this may impact on U.K. law too.
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