A potential class action is being investigated after a packaging error involving contraceptive pills allegedly resulted in unintended pregnancies among women who used an affected batch between 2023 and 2025.
The issue relates to certain packs of Yaz Plus contraceptives, which were found to contain the pills in the wrong sequence.
Instead of containing 24 active hormone tablets followed by four placebo tablets, some affected packs contained 24 placebo tablets and only four active tablets.
Almost 500 women have contacted law firm LHL Attorneys about possible legal action, according to senior associate Demi Buckley.
However, Buckley stressed that the figure represents enquiries received by the firm and does not mean that all of the women are confirmed claimants or have formally joined court proceedings.
She said the firm was aware of the recall in 2024 but initially monitored the situation before deciding to investigate potential legal action after receiving an increasing number of calls from affected women.
The number of enquiries reportedly increased after the potential lawsuit received media attention.
Recall highlighted packaging error
The problem came to light on 18 November 2024, when Bayer South Africa, in consultation with the South African Health Products Regulatory Authority (SAHPRA), recalled batch WEW96J of Yaz Plus oral contraceptives.
SAHPRA said the affected batch had been distributed on 9 and 24 November 2023 and remained in circulation for approximately a year before the recall.
Buckley said the recall was significant because it confirmed that certain blister packs had been incorrectly packaged.
“The official recall strengthens our case as there is no dispute that certain blister packs had a reversed pill sequence due to a mispackaging error,” she said.
She added that the packaging error would have affected the contraceptive efficacy of the affected batch.
However, the recall does not automatically establish legal liability in every individual case.
Buckley said women seeking compensation would still need to prove their claims on a balance of probabilities and provide evidence linking their circumstances to the affected contraceptive batch.
Lawyers gathering evidence
LHL Attorneys said it has received enquiries from women in several provinces, although no clear pattern has emerged based on location, age or the timing of pregnancies.
The firm is assisting potential claimants with gathering medical and pharmacy records to determine whether they may have grounds for a claim.
These records could include prescription and pharmacy dispensing information, medical records and documentation relating to pregnancies.
Where an unintended pregnancy resulted in a birth, the firm may also require documents such as the child's birth certificate. In cases involving miscarriage, stillbirth or termination, relevant medical records may also be considered.
Buckley said individual circumstances would be important in determining whether a woman's experience could be linked to the defective batch.
Court approval still required
The matter is currently being investigated as a potential class action and has not yet been certified as one by a court.
In South Africa, a court must authorise litigation to proceed as a class action before multiple claims can formally be pursued under that process.
LHL Attorneys said it intends to submit a certification application once its investigation has been completed and sufficient supporting evidence has been gathered.
The firm is targeting 2027 for the application.
Buckley said a class action could allow women who were similarly affected by the same alleged packaging error to pursue their claims collectively, potentially reducing the cost and time involved compared with separate legal proceedings.
If the court does not approve the class action, the firm could still assist affected women with pursuing individual claims.
Compensation could depend on individual circumstances
The potential damages in each case would depend on the impact of the unintended pregnancy and the circumstances of the individual claimant.
Potential claims could include medical expenses related to pregnancy and childbirth, income lost because of unpaid maternity leave, and damages linked to emotional trauma following miscarriages or terminations.
In cases where a child was born following an alleged unintended pregnancy, the firm said potential claims could also include costs associated with raising the child, such as food, nappies and schooling.
No specific compensation amount has been determined at this stage.
The law firm said it is continuing to gather evidence before deciding on the next steps in the potential legal action.
Based on reporting by The Citizen