Worsley v Tambrands Limited

Worsley v Tambrands Limited

Decision of Mrs Justice Ebsworth 3 December 1999

This claim related to the extent of warnings provided with tampons in relation to toxic shock syndrome (TSS): the claim failed.

Procedure: submission of no case

Procedurally, this case was decided on the novel basis of a submission by the defendant of no case. The judge considered that she had a discretion to adopt such a procedure under the Civil Procedure Rules as being in the interests of economy and the best use of the court's resources, and that she had a discretion whether or not to put the defendant to its election whether or not to call evidence. The case was decided on the claimant's issue alone and although the judge heard expert evidence of both the claimant and the defendant, that evidence played no part in her judgment.

The warnings given

TSS is a rare illness which most medical practitioners will never have seen. It is caused by toxins produced by certain strains of Staphylococcus Aureus (SA), a common bacteria which lives harmlessly on the skin and in certain orifices. A particular toxin produced by SA is believed to be responsible for causing most if not all menstrually-associated cases of TSS.

The manufacturers' labelling of the product, on the box and the enclosed leaflet, were altered over time. From at least 1982, there was some mention of an association with TSS. At the time of the incident in 1994, the box included the words "Attention: Tampax are associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and save the enclosed leaflet." The judge found that the claimant was familiar with that wording.

The 1991 leaflet included the wording:

"Personal health advice. Toxic shock syndrome (TSS). TSS is a rare condition that has been associated with tampon use. TSS can rapidly progress from flu-like symptoms to a serious illness that can be fatal. The warning signs of TSS include a sudden high fever, usually over 102 degrees Fahrenheit, 39 degrees Celsius, vomiting, diarrhoea, a sunburn-like rash, sore throat, dizziness, fainting or feeling faint. If you have any of these symptoms and are using a tampon, remove it and contact your doctor for immediate treatment, telling him you have been using a tampon. Do not use a tampon again without your doctor's advice.

"The risk of TSS is believed to be related to tampon absorbency. Always use the lowest absorbency for your flow."

The 1993 leaflet also had the words:

"If you have any of these symptoms and are using a tampon, remove it and contact your doctor for immediate treatment, telling him you have been using a tampon. Do not use a tampon again without your doctor's advice".

The claimant's knowledge and belief

The claimant was 29 at the time of the incident in 1994. The judge found her to be an intelligent graduate primary school teacher. She had used tampons since she was 15 or 16, primarily the defendant's brand, Tampax Regular. She had read the leaflet at an early stage and had read some of the subsequent revisions to the leaflet. She had also read a magazine article about TSS. Her belief was that it was only possible to get TSS if she retained a tampon in for too long. She recognised that TSS was a real possibility and was serious, with rapid onset and that a sufferer would be seriously ill.

She believed that TSS had a rapid progression in severity towards that which was possibly fatal. However, the judge found that the leaflets contain nothing to suggest that you could only get TSS if you retained the tampon beyond the advised period, and nothing suggested that TSS would only be rapid onset leading to death or collapse within 24 to 48 hours.

The facts of the injury

In July 1994, the claimant began a period on a Saturday. She inserted a tampon from a box of 32 bought at a local supermarket in June. It was her habit to change tampons regularly every 3 or 4 hours except during the night. On the Saturday evening, she went to a wedding reception. She awoke at 4 am on the Sunday with diarrhoea and vomiting, which she thought was food poisoning. She continued feeling ill for some days, but continued working. On the Tuesday evening, she switched from a tampon to a sanitary pad for a period of 2 or 3 hours. Although no evidence was given on the point, the judge made the inference that she did that because she recalled the leaflet warning to remove the tampon if any of the TSS symptoms were present. She then talked to her husband about TSS and checked the box for the leaflet. The leaflet was not available because her husband had thrown it away when he had opened the box of tampons on the Saturday. The claimant did not seek medical advice at that stage. She continued working on the Thursday, with diarrhoea and flu-like symptoms which got worse, prompting her to visit her doctor at 5 pm on the Thursday. She confirmed to the doctor that she was menstruating but made no mention of her tampon use or concern about TSS. The doctor diagnosed that she had food poisoning and sent her home to bed. Her condition deteriorated rapidly until she was admitted to the hospital on Saturday, following which the tampon which was then in use was removed and a vaginal swab showed a heavy growth of SA.

Where do you put information: box or leaflet?

The judge rejected the complaint that the defendant ought to have foreseen that the leaflet might not be kept and/or read and that the health warning, including the list of likely symptoms and advice on how to react to them, ought to have been printed in full on the outside of the package. The judge noted that the box for the same product was marketed in USA and internationally at the time had the same warning. She held:

"As a matter of common sense, I conclude that the duty of the manufacturer, and that which persons generally are entitled to expect in relation to the product, is that the box contains an unambiguous and clear warning that there is an association between the TSS and tampon use and directs the menstruating woman to the internal leaflet for full details.

TSS is a rare but potentially very serious condition which may be life threatening, but it is necessary to balance the rarity and the gravity. That balance is reasonably, properly and safely struck by the dual system of a risk warning on the box and a full explanation in the leaflet if the former is clearly visible and the latter is both legible and full".

How emphatic should a warning be?

The claimant accepted that the content of the leaflet was true, accurate and essentially complete. The judge rejected the complaint that the wording was not sufficiently emphatic and did not make clear that the onset of the illness might be slow and present with symptoms which might be mistaken for those of other illnesses such as food poisoning. The judge noted that the wording:

"If you have any of these symptoms and are using a tampon, remove it and contact your doctor for immediate treatment, telling him you have been using a tampon".

She held that wording to be clear and sufficient to draw the attention of the user to the necessary course of action in presence of any one of the symptoms.

As a matter of causation, the judge noted that the claimant had removed her tampon on the Tuesday evening but had chosen to replace it and not go to the doctor on that day. On the Thursday when she did go to the doctor, she did not tell him she was using a tampon, notwithstanding that she had told him when he asked that she was menstruating. The judge that the reason why she did not act on the warnings was that she had in effect lost the leaflet.

The judge also rejected the complaint that the leaflet was designed in such a way that it did not have a sufficient impact on her, whereas the US warnings at the time were more prominent, fuller and would have had a greater impact. The judge noted that the 1994 US leaflet was a single-language document (the UK version was multilingual) with the warning in larger type. It also contained advice on how to reduce the risk of TSS by alternating tampon and towel use, or by not using tampons at all. The judge accepted that the US model was better than the UK one, but held that that was irrelevant. She held that the UK labelling did not fall below the legal standard by reason of its design and/or contents. The wording was legible without undue effort. The judge rejected the allegation that the warnings on the leaflet should have been designed to make a greater impact on the claimant's memory. The judge noted that the claimant had read some at least of the leaflets over the previous years and said:

"Whilst I accept that reading leaflets repeatedly over the years may have a cumulative effect upon the reader, I do not consider that they should be designed so to do. The impact needs to be fully present in each one. A different design or content in earlier leaflets would not have altered the claimants' reaction."

The judge accepted that had the claimant kept the leaflet, she would have looked at it on the Tuesday night. The judge concluded by saying that the reality of this case was that the claimant had lost the leaflet and had misremembered its contents.

"That does not render the box or the leaflet defective, and the claim must fail. The defendant had done what a menstruating woman was, in all the circumstances, entitled to expect: (1) they had a clearly legible warning on the outside of the box directing the user to the leaflet; (2) the leaflet was legible, literate, and unambiguous and cnotained all the material necessary to convey both the warning signs and the action required if any of them were present; and (3) they cannot cater for lost leaflets or for those who choose not to replace them, as the claimant could have done after the Tuesday when she discovered the loss".

For further information, please contact Christopher Hodges on tel: 0171 367 2738 or e-mail: [email protected]