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In April of 2014, the FDA issued a statement about the use of power morcellators as part of hysterectomy procedures that prompted Ethicon to issue a worldwide market withdrawal of its morcellator lines but the procedures themselves were allowed to continue. By November, the FDA went one step short of a total ban on morcellator use by warning doctors not to use them in hysterectomies and fibroid removal surgeries. The warning suggested that the devices should not be used in the vast majority of surgeries in women and morcellation should be the very last resort due to the associated health risks.
Timeline of Events
The latest statement by the FDA marks the latest in an eight year long series of events that led to the market withdrawal of power morcellators by Ethicon and the eventual warnings about their use. Ethicon parent company, Johnson and Johnson is currently under fire for failing to communicate the risks of morcellator use to doctors and patients after concerns were raised over eight years ago. The following is the progression of events that led to the latest statement from the FDA.
- Early 2006— A pathologist at Evangelical Community Hospital in Lewisburg, Pennsylvania communicated concerns to Johnson and Johnson in writing after discovering that power morcellators caused the dissemination of tissue and that this would lead to the formation of fibroids or the spread of undetected cancer.
- May 10, 2006— Ethicon dismissed the concerns in a letter and refused to act despite an appeal by Dr. Robert Lamparter, the original complainant, citing that prescreening for uterine cancer prior to laparoscopic hysterectomies is not always effective and that the tissue dissemination caused by morcellation can seed cancer or cause it to progress into advanced stages quickly at the jeopardy of the patient’s life.
- The first lawsuit against power morcellator manufacturers is filed by the widower of a woman who died of uterine cancer within a year of undergoing a laparoscopic hysterectomy.
- April of 2014— The FDA issues a warning against power morcellator use after research concludes that dissemination of tissue during hysterectomies can result in numerous medical complications which include numerous forms of uterine cancer.
- Also in April of 2014— Johnson and Johnson announces the market withdrawal of all Ethicon power morcellator lines but declines to issue a recall of devices already sold.
- November of 2014— The FDA issues a statement warning against the use of power morcellation in the majority of hysterectomies.
If you were injured or developed cancer following a procedure that involved the use power morcellation, you may be entitled to compensation for your injuries, pain and suffering, change of lifestyle and additional costs incurred due to your injuries. Contact us today to speak with an experienced and qualified lawyer who will arrange to meet with you during a free consultation. During your consultation, we will be happy to review the details of your case, answer your questions about your rights, options and the legal process and let you know how best to proceed with your case. Our attorneys work on a contingency basis, which means we will never demand payment upfront and will only receive payment once we have secured compensation on your behalf.