Power Morcellator lawsuits have been filed across the country by patients who allege that they have suffered harm because the device caused cancer to spread within their bodies. These lawsuits have attracted the attention of lawmakers in Washington, D.C. Rep. Mike Fitzpatrick called for the U.S. Food and Drug Administration (FDA) to investigate the injuries and deaths linked to power morcellators manufactured by Ethicon, a subsidiary of Johnson & Johnson. As a result, 12 members of Congress have opened an investigation into the potential dangers regarding power morcellators.
Why Did The Congressman Start an Investigation?
The investigation was started to see why it took 20 years for the FDA to issue a warning to patients about power morcellators and to see if the manufacturers knew of the risks of using the device. Under the FDA’s Medical Device Reporting regulations, the potential dangers posed to patients by morcellation should have been caught right away. Moreover, manufacturers had a responsibility to report these possible dangers to the FDA immediately. But this did not happen. The regulations failed and the manufacturers did not provide any warnings, despite possibly knowing of the dangers from negative reports.
How Is The Investigation Being Conducted?
There are two major parts to the investigation. First, the investigation questions if the approval process that power morcellators underwent was adequate. The FDA cleared power morcellators in 1995 under its 510(k) clearance process. This a different approval process where manufacturers only have to show that the device is similar to another device already on the market. After approval, manufacturers are supposed to monitor any adverse events while it is being used. Second, the Federal Bureau of Investigation (FBI) started an investigation regarding if Johnson & Johnson knew about the potential dangers of the device. The FBI could pursue criminal charges if there is evidence of wrongdoing.
Contact a Power Morcellator Lawyer
If you or someone you know has suffered harmful side effects after being treated with a power morcellator, contact d’Oliveira & Associates. You may be able to receive compensation for your medical bills, lost income and pain and suffering, among other losses. Our firm is working with experienced power morcellator lawyers across the country, who are investigating these cases and they may be able to file a power morcellator lawsuit for you. They charge no fee unless you win an award or settlement. For a free (no obligation) case evaluation, call us toll free at 1-800-992-6878 or fill out a contact form online.