The number of hysterectomy operations in the United States each year exceeds 500,000. Of that number, approximately 55,000 involved the use of power morcellation devices between 1995 (when they were licensed for use in gynecological surgery) and 2014 (when the FDA started to issue warnings against their use in certain circumstances).
Based on these numbers, well over a million hysterectomy surgeries have been performed with the aid of power morcellators. Of that number the FDA estimated that 1 in 350 that used power morcellators may have caused cancer to spread beyond its initial primary site and been the cause of unnecessary suffering and death in hysterectomy patients. This means that just counting hysterectomy procedures alone over that 19 year period, approximately 3,000 patients may have suffered as a direct result of their use. These victims and their families may be entitled to recover damages through product liability litigation.
There are three main hurdles in the way of proving damages in a power morcellation case:
- What was the state of the pre-existing cancer?
This may be difficult to prove as power morcellators are typically used only where the treated tissue is diagnosed as being benign. One of the key diagnosis weaknesses that the FDA warnings in April and November 2014 revealed was that in a small, but significant number of hysterectomies involving uterine fibroid tumors (approximately 1 in 350), the supposedly “benign” fibroid tissue could hide cancerous tissue. In these cases, a power morcellator might have spread the cancer in the patient.
There may be significant challenges in establishing a baseline of health. It should be noted however that there is the potential to extrapolate this, to some extent at least, from the rate of development of the cancer. One of the key issues with power morcellators is that they facilitate the spread of cancer to new sites, the spread rate and its deviation from the norm is critical to establishing a causal link.
- What is the likely survival rate?
The second big hurdle is that cancer is present in all cases and so any damages need to be argued in the context of how much difference the use of the power morcellator made to the patient’s suffering and life-expectancy.
According to one July 2002 study for example, only 10% of women who have advanced stage leiomyosarcoma can expect to live beyond 5 years.
Any damages may therefore need to be set in context of how much difference any spread of cancer (assuming it is proven) has made to the patients final life-expectancy.
- How has the patients quality of life been affected?
This third question is predicated on an analysis of what a patient’s quality of life would have been like both with and without her cancer spreading.
In order to argue this effectively, it is necessary to draw on similar patient profiles both with and without the cancer spreading.
In this way it is possible to draw meaningful conclusions as to how the spread of cancer that was caused by the use of a power morcellator has impacted an individual patient, and what damages she or her family may be entitled to recover.