In late May 2015, the FBI began investigating Johnson & Johnson in connection with its manufacture of power morcellator devices, surgical tools used to cut and remove fibroid tissue in women through a minimally invasive surgery. Johnson & Johnson, who manufactures the devices through its Ethicon subsidiary, is the world’s largest manufacturer of the device by a large margin.
In June 2014, due to mounting concerns and controversy over the safety of morcellation devices, Johnson & Johnson suspended sales of power morcellators and pulled its devices from the market. Johnson & Johnson’s actions were in response to action by the U.S. FDA in 2014, in which they released a safety communication connecting the use of power morcellators in hysterectomies and myomectomies to the spread of malignant tumors, such as leiomyosarcoma and uterine sarcoma. According to the FDA, this spread of malignant tissue can result in a rapid upstaging of cancer, lowering survival rates considerably among patients. In November 2014, the FDA issued a “black box warning” in which it warned against use of morcellation devices in women who present with a high cancer risk, namely those who are peri- or post-menopausal and in those women in which fibroid tissue is known or suspected to contain a malignancy.
Now, the FBI is investigating what Johnson & Johnson knew about these dangers and when they knew it. At least one patient, Dr. Amy Reed from Pennsylvania, has been interviewed by the FBI about her case. FBI agents have also interviewed a pathologist who allegedly alerted Johnson & Johnson about the dangers of morcellators in 2013.
The pathologist is a man named Dr. Robert Lamparter, who contacted Ethicon after he noticed an increase in malignant morcellated samples of tissue showing up in his laboaratory. Dr. Lamparter wrote to Johnson & Johnson in a February 2006 email that “f a morcellation is done, the patient’s survival is jeopardized.” Further, Dr. Lamparter told Johnson & Johnson that if cancer is present in a morcellated fibroid, it “may lead to the dissemination of malignant tissue.”
The FBI’s investigation is the latest in a series of hits taken by Johnson & Johnson and other manufacturers concerning their morcellation devices. Aside from the strong FDA action throughout 2014, many of the nation’s most prominent hospitals and largest health insurance carriers have curtailed or altogether eliminated use of morcellators. Further, this issue has attracted the attention of numerous lawmakers, with Senator Robert Casey and Representative Michael Fitzpatrick—both from Pennsylvania—pressuring the FDA to respond more forcefully to the dangers of power morcellation devices.
To date, over 20 lawsuits have been filed and are pending in federal courts throughout the country against the manufacturers of these products, including Johnson & Johnson. Ashcraft & Gerel is aggressively pursuing justice for individuals who have been harmed or lost loved ones due to the negligence of the corporations who designed and manufactured power morcellation devices. If you or a loved one were diagnosed with cancer after undergoing a morcellation-aided surgery, you may have a case. Please contact us online or call us at (800) 674-9725 to discuss how we may assist you.