The FDA has issued two warnings against the use of power morcellators in certain gynecological surgeries. The first in April 2014 to highlight that 1 in 350 women will have an undetected sarcoma that can potentially have lethal consequences if the devices are used. With a second in November 2014 to further make clear when the devices should not be used and also to make sure that manufacturers of the devices have clear labeling that indicates those circumstances.
Since that time, a growing number of lawsuits have arisen as a result. Here are three legal avenues that are being explored to get redress for those killed or injured through the use of power morcellators:
- Insufficient warnings on the power morcellation devices regarding use.
The November 2014 FDA statement started to draw together the available scientific evidence into the use of power morcellators into a specific warning regime. The devices have however been licensed for use since 1995 in gynecological surgeries, so there is a period of 19 years where there were insufficient warnings on the devices.
- Defective design of power morcellators.
This hinges on whether or not the design of power morcellators is fit for the purpose of uterine surgeries. A defective design argument takes the position that, prior to the 2014 FDA warnings, the manufacturers knew or should have known that certain uterine fibroids contain sarcomas. Given that, the argument continues that the design of the devices was inherently defective and that alternative designs should have been pursued. For example, it has been suggested that power morcellators that use isolation bags, which ensure that no tissue passes to other sites when the devices are used, are designs that manufacturers should be implementing.
- The timing and cause of the cancer in the patient.
The specific timing and cause of a cancer incident is critical to any power morcellation case. It needs to be established when the cancer became evident and also what caused it. There needs to be specific causation between the use of a power morcellator device, and the development of a sarcoma. In practice this means that patient medical records will need to be closely examined, as well as results from imaging, pathology reports and any other patient medical records. There needs to be both a timescale in the development of the sarcoma that can be shown to be causally linked and an outcome that is not favorable to the patient due to the use of the device.
In practice this means that the amount of time that it takes the cancer to spread will be a key component in any legal case. Over the years these devices have been very widely used in gynecological surgeries and so there is a definite pattern that can be shown both for cases where the treatment works as expected and conversely where it has not.
The key to showing this is often the speed at which the cancer has spread. The faster the spread that can be demonstrated through patient records, the more easy it will be to show causation.