You chose the Ballerine because you think it will protect you. But then it happens: you get an unwanted pregnancy. Or the IUD gets stuck in your uterus and cannot be easily removed. You have to undergo painful surgery with all its consequences.
Women report to us with these problems. And they ask the same questions: why wasn't I warned? Could this have been prevented? Who is responsible?
In this blog, we answer those questions. We look at the regulations surrounding producer liability and what is legally possible.
When do we speak of product liability?
The law provides that a producer is liable for damages caused by a defective product. In doing so, the victim does not first have to prove that the producer acted negligently. A ‘strict liability’ rests on the producer.
Product liability thus revolves around whether a product is defective and whether it offered the safety one would expect. This includes how the product was presented, how it is normally used and what was known about its safety at the time.
It sounds simple on paper, but in practice, with medical devices, it is often more complicated. It takes expert reports - from a gynecologist, for example - to prove that a product was not safe.
The difference between a medical device and a drug
It makes a difference what kind of device was used. Different rules apply to the Ballerin than to a hormone IUD, for example. A hormone IUD (such as the Mirena) qualifies as a drug, but a copper IUD (such as the Ballerin) qualifies as a medical device.
Authorization requirements for medical devices are structurally different from those for pharmaceuticals, and in several respects less onerous. A different system of market authorization, evidence, surveillance structure and pre-market control applies to both groups.
An important difference is that for medical devices there is no central public pre-market control. A government body does not assess the content before market authorization: that role is delegated to private parties. For pharmaceuticals, however, a substantive assessment by a government agency does take place before market authorization and a marketing authorization is required.
The manufacturer of an IUD must demonstrate through clinical trials that the drug is both safe and effective, with a higher standard of evidence. The manufacturer of a copper IUD can suffice with a clinical evaluation based on existing evidence. Side effect monitoring is also different; the hormone coil is subject to stricter pharmacovigilance requirements than the copper coil.
The hormone coil/copper coil distinction shows that similar-looking products with similar uses fall under different product safety regimes.
Information not shared
Medical devices may behave differently than expected after being introduced to the market. New reports from users and physicians may indicate complications, side effects or practical problems that were not initially anticipated. With the Ballerin, it became clear at one point that (i) more pregnancies were reported than anticipated and (ii) difficulties often existed when the IUD was removed because it was stuck in the uterus. This information was not shared with patients and physicians by the manufacturer. While it is crucial that this information be shared quickly and clearly with patients and physicians. Only then can they make informed choices and doctors adjust their practices. This touches on a core responsibility of manufacturers and may be relevant to whether they are liable.
Time is important
Those who believe they have damage from the Ballerine do not have unlimited time. With product liability, the statute of limitations is three years after you became aware of the damage, the defect and the party liable for it. We apply the time when you found out that you became pregnant, or the time when it was clear the Ballerin could not be easily removed at the first attempt. You can interrupt this period by taking timely action. The clock then stops, and a new three-year term begins.
In addition, there is an absolute limitation period of ten years after the product is put into circulation. This is a hard limit: after those ten years, your product liability claim expires.
Sometimes another basis can then be considered, such as tort. The statute of limitations is then five years from the moment of awareness of the damage and the party liable for it. But that requires a different substantiation and does not make the case easier.
This is precisely why it is important to report on time.
Now what?
If you have experienced problems with the Ballerine - unwanted pregnancy or difficulty in removal - we are curious to hear your story.
We are happy to determine with you what steps are possible.
