Who knew what, and when did they know it?
That is the question that the Federal Drug Administration (FDA) must answer…and the agency’s answer could determine whether there is any criminal liability for the harm that hundreds or thousands of women in the United States have suffered after gynecological surgery with a power morcellator. Power morcellators are used to break down the uterus or uterine fibroids before removing the tissue from the body. However, if cancer cells are present, then the device may spread cancer throughout the pelvis and abdomen.
The FDA issued a safety warning about these medical devices in April 2014, years after they had first been used in the United States. Johnson & Johnson, the largest manufacturer of power morcellators, voluntarily withdrew the medical devices from the market later that year.
Was It Too Little Too Late?
In December 2015, U.S. Representative Mike Fitzpatrick wrote a letter to the Director of the Office of Criminal Investigations at the FDA asking that the agency look into whether hospitals such as Brigham and Women’s in Boston and the University of Rochester Medical Center in New York and the device manufacturer, Johnson & Johnson, failed to report harm to patients who underwent power morcellator surgeries as required by federal regulations.
Representative Fitzpatrick is not the only government official questioning whether the FDA’s patient safety regulations may have failed the public in the decades that power morcellators were used in gynecological surgeries. The House Committee on Energy and Commerce raised similar concerns during a November 2015 hearing. Additionally, the Federal Bureau of Investigation (FBI) is reportedly looking into what Johnson & Johnson knew and when it knew it.
As the government continues to investigate any potential criminal liability related to the use of power morcellators, it is also important for injured women, or their surviving loved ones, to take action. Those who have been hurt, or the survivors of those who have died, may have the right to recover damages, but action must be taken beyond reporting the injury to the FDA. Please read our FREE report, Power Morcellators: What You Need to Know About Them, today to learn more.