In a decision of the Federal Court in Western Australia, a breast imaging provider company was found to have engaged in misleading and deceptive conduct and made false representations about the devices it used in its screening services.

Breast Check Pty Limited offered breast imaging services using a device known as the Multifrequency Electrical Impedance Mammograph (MEM) and various infrared imaging devices for digital thermography. It provided women who had purchased these services with a breast health report and an information package which included one or more of report information, a breast imaging pamphlet, a thermography pamphlet and a pamphlet describing the services offered by Breast Check.

Three promotional pamphlets were also available at Breast Check’s clinic, one being a breast imaging pamphlet, one advertising the use of thermography devices for breast imaging and one entitled “Our Services to You”.

The representations

The ACCC alleged that Breast Check, via the pamphlets, represented that:

  • Breast imaging done using a thermography device, either alone or in conjunction with the MEM, could provide an adequate scientific medical basis for assessing whether the woman imaged may be at risk from breast cancer, and if so, the level of such risk, when there was and is inadequate scientific medical basis for that representation.
  • Breast imaging using either a thermography device alone, or in conjunction with the MEM, could provide an adequate scientific basis for assuring the woman imaged that she did not have breast cancer, when there was and is inadequate scientific medical basis for that representation.
  • There is an adequate scientific medical basis for using either the thermography device along, or in conjunction with the MEM, as a substitute for mammography, when there was and is an inadequate scientific medical basis for that representation.

“Publicly” available?

A substantial issue in the proceedings was whether the pamphlets were available to the public or whether they were, as Breast Check argued, provided to women who were given a further detailed explanation about the imaging. Justice Barker found that women interested to enquire about the services were able, by dropping into the clinic or by calling it, to obtain the pamphlets and were not systematically provided with any information which qualified the content of the representations conveyed by the pamphlets.

Were the pamphlets misleading?

Having decided that the pamphlets were available to a class of the public, the issue was whether the pamphlets were misleading.

The ACCC relied upon expert evidence in mounting its case that the representations were misleading. That evidence included that on average, thermography for breast imaging identifies less than half of the women who had breast cancer and also is incorrectly positive in more than a quarter to a third of women who did not have breast cancer, indicating the test is not reliable. The evidence was also that mammography detects 2 – 3 times the proportion of breast cancers detected with thermography.

In deciding that two of the pamphlets were misleading, his Honour stated that “it would be entirely reasonable for a consumer to conclude that, where a service of a medical nature is being provided, there would be medical evidence of a sufficient quality to support the use of the equipment used to provide such a service and that the area of breast imaging devices would not be promoted in a way as to be contrary to the state of scientific medical knowledge”.

His Honour found there was no such medical evidence and that the representations were misleading.

Of note, his Honour found that the use of permissive words in the pamphlets, such as “may” and “can” did not qualify or negate the representations conveyed by the pamphlets.

Knowing concern

The Court also found that a doctor employed by Breast Check was knowingly concerned in and a party to the contraventions of Breast Check. The doctor had authored the pamphlets. She was unaware whether studies existed to establish that thermography could be used to assess risk or provide an assurance.

This was taken by the Court as evidence that she knew there was an inadequate scientific medical basis for Breast Check’s representations. That was sufficient for the Court to find she was knowingly concerned or involved in the contraventions of Breast Check.

The Court adjourned the matter to hear submissions about the appropriate relief to be ordered.

Takeaways

The decision emphasises the care which must be taken to ensure that promotional material is not misleading. Even the use of permissive words like “can” or “may” were found not to qualify the representations conveyed.

Individuals involved in the preparation of promotional material need to be satisfied they are not aware of information which may call into question the accuracy of the representations made.