Doctors and company to be held liable for contraceptive failureBMJ 2005; 330 doi: https://doi.org/10.1136/bmj.330.7506.1467 (Published 23 June 2005) Cite this as: BMJ 2005;330:1467
A court in Holland has ruled that 15 women who became pregnant despite using the contraceptive implant Implanon are entitled to be paid damages for their “unintentional pregnancy.” But whether Organon, the Netherlands based company that marketed Implanon, or the individual doctors who inserted it are liable remains unanswered.
The court concluded that both should pay damages unless either can bring further evidence. The doctors need to prove that the product was faulty and that they inserted it properly, Organon the opposite.
The decision covers 15 cases brought by the women against Organon and 13 brought against their doctors. Their pregnancies led to 10 births, four abortions, and one miscarriage. The amount of damages could be considerable, as it could include the cost of bringing up the children until the age of 18 years.
Organon launched Implanon in the Netherlands and abroad in 1999. It consists of a small flexible rod or stick that is inserted under the skin of the upper arm. A special applicator or needle designed by Organon is used to insert it.
The implant releases the hormone etonogestrel, protecting against pregnancy for three years. Doctors can check the implant, after it has been inserted, simply by feeling it, or by ultrasonography, magnetic resonance imaging, or a blood test.
In none of the women was any trace found of the implant when they were checked after they became pregnant. Blood tests confirmed that it was not in their bodies.
The doctors' lawyers argued that the pregnancies were a result of a fault in the contraceptive or because the implant had been expelled from their bodies unnoticed, through movement of the arm, before the wound healed.
Organon argued that it would be impossible not to notice such an occurrence, as it would have been accompanied by an infection. It argued that the failure of the contraceptive was due to a mistake by the doctors in inserting the implant.
The court concluded that further expert investigation was needed to prove the cause. However, it said that all possible causes lead back to either faulty treatment or a faulty product, or both, so both Organon and the doctors were liable and should, in principle, pay compensation.
The women's lawyer, August Van, said it was a very important decision. “Whatever the cause of their pregnancies my clients now know for sure that they will get compensation.” The court had “diverged from the normal rules” by agreeing that the women “did not have to prove negligence,” he said.
A lawyer for the doctors, Michel de Ridder, said that this “reversal of the burden of proof” whereby doctors had to prove their innocence without knowing everything that had happened was “unfair.”
Organon is studying the judgment and may appeal, but a spokeswoman said: “We believe that Implanon, if inserted correctly, is a safe and reliable contraceptive. Since its introduction 20 000 women in the Netherlands have used Implanon and 1.5 million women worldwide.”