Lawsuit Contends J&J Knew About Power Morcellator Problems
Lawsuits against Johnson & Johnson regarding its laparoscopic power morcellator medical device have prompted an FBI investigation into allegations that Johnson & Johnson knew about dangers associated with the medical device before pulling it from the market in 2014. Allegations state that Johnson & Johnson knew the laparoscopic power morcellator could potentially spread undetected uterine cancer during fibroid removal surgeries, hysterectomies, and myomectomies.
How Cancer Is Spread By A Power Morcellator
The laparoscopic power morcellator is inserted through a small opening and acts like a drill tearing apart uterine tissue and fibroids. However, lawsuits allege that the tool also uncovers cancer cells causing them to spread throughout the patient’s body.
Lawsuits filed in district court allege Johnson & Johnson knew about the defective medical device but hid that knowledge so that it could continue to sell the medical device. It is unknown for how long Johnson & Johnson may have known about the potential for danger; however, a former pathologist at Evangelical Community Hospital in Lewisburg, PA, Robert Lamparter, sent correspondence to the Johnson & Johnson subsidiary that sold the laparoscopic power morcellator relating his concerns. Lamparter included several concerns in his correspondence with Johnson & Johnson “which didn’t exclude the potential for an undetected cancer to be inadvertently spread by the surgical instrument.”
FDA Announced Black Box Warning – It’s Strongest
In April 2014, the Food and Drug Administration (FDA) claimed that patients undergoing fibroid surgery could be at risk due to dangerous uterine sarcoma that “can’t be reliably detected before the operation.” The laparoscopic power morcellator was spreading the previously undetected cancer in approximately 1 out of every 350 surgeries where the medical device was used. The FDA called for its strongest warning, a “black box” warning, of the potential risk.
Lawsuits Also Prompt Renewed Questions of FDA 501(k) Process
In August 2012, U.S. Senator Jeff Merkley and Congressman Edward J. Markey sent a letter to the FDA concerning “weaknesses in the premarket review process used to evaluate most medical devices.” The letter called for the FDA to review and change its Recalls and 401(k) Premarket Notification databases to provide information regarding the safety of medical devices. The letter states that the 501(k) process allows defective medical devices to go to market because the FDA is not actually approving the devices but simply “clearing” the devices for sale. The process allows manufacturers of medical devices to “fast track” the sale of medical devices without the necessary clinical trials.
Under the 501(k) process, if a medical device manufacturer can demonstrate that a medical device is “substantially equivalent” to a device that is already on the market (a “predicate” device), the FDA is required to clear the device for sale. The FDA only requires human testing of medical devices in very few cases before clearing them to be sold. Furthermore, the FDA clears medical devices that have the same flaws as predicate devices that have been recalled. No real changes have been made to the FDA’s 501(k) process to provide more protection to the general public.
Have You Been Injured by a Defective Medical Device?
The New Orleans, Louisiana attorneys of the Olinde Firm can help you if you or a family member has been injured by a defective medical device, dangerous drug, or recalled product. You have the legal right to recover compensation for your damages from the company responsible for the defective product.
For more information and a free case evaluation, contact our office by calling 1-800-587-1889 or contact us online. We represent clients in defective product cases in Louisiana and throughout the United States.