Congress proposes medical device defects reporting bill in response to delayed reports of link between laparoscopic power morcellators and uterine cancer

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by Michael Heygood

A bipartisan bill introduced to Congress recently would require doctors to report potentially serious medical device defects to the Food and Drug Administration. The proposed bill, known as Medical Device Guardian’s Act, was drafted in response to recent concerns about a women’s surgical tool known as laparoscopic power morcellators, which is used during hysterectomy surgery.

Although FDA regulations require hospitals and medical device manufacturers to report cases of death or serious injury caused by medical devices to the agency, the co-sponsors of the bill say that under the current federal law, the responsibility for reporting medical device defects has been left in the hands of patients. Under the new bill, doctors and doctors’ offices would be added to the FDA’s list of mandated reporters for adverse events and product defects linked to medical devices. The bill also contains safeguards that would prevent adverse event and medical device defect reports made by doctors from being used against them in civil litigation.

In 2014, the FDA issued a “black box warning” for laparoscopic power morcellators following reports that the device could increase a woman’s risk of developing uterine cancer. Although studies had warned about the increased risk of uterine cancer associated with laparoscopic power morcellators since the 1990s, the FDA only became aware of these risks when a Massachusetts doctor went public with her concerns following hysterectomy surgery.

Although the FDA says that the new bill would help to address problems with the underreporting of medical device defects, the agency says that it is planning additional measures to help in this area. The FDA is currently planning to create a nationwide patient evaluation system that would utilize data generated during patient care to identify safety issues and defects in medical devices more rapidly.

Following reports linking laparoscopic power morcellators to an increased risk of uterine cancer, Johnson & Johnson suspended sales of these medical devices in April 2014 and recalled them from the market in July of that year. Johnson & Johnson has reached settlements in more than 100 product liability lawsuits filed against the company and its Ethicon subdivision regarding the link between laparoscopic power morcellators and uterine cancer. Dozens of lawsuits involving laparoscopic power morcellators are currently pending against other medical device manufacturers, including Karl Storz GmbH, which currently faces more than 40 lawsuits in California state court.

Medical Device Defects Lawsuits Filed by Heygood, Orr & Pearson

Patients who have been injured by laparoscopic power morcellators or other medical device may be eligible to file a lawsuit against the manufacture for the injuries they have suffered. To successfully bring a claim involving a medical device or other defective product, patients need the assistance of a lawyer with the training and experience to handle their case, as well as the financial resources to pursue their claim in full and, if necessary, take their case to trial.

The lawyers at Heygood, Orr & Pearson have resolved hundreds of claims involving defective medical products, dangerous drugs, and medical malpractice on the part of doctors or hospitals. Our attorneys have secured verdicts and settlements for our clients totaling more than $200 million. We not only have the financial resources to take a case to trial, but the legal expertise to ensure that your legal rights are protected in a court of law.

At Heygood, Orr & Pearson, we believe that when companies who manufacture medical devices fail to properly ensure that their products meet minimum health and safety standards, they should be held accountable for the injuries and illnesses caused by their products. We believe that all patients deserve access to qualified legal counsel to represent their interests and ensure that their rights our protected.

For a free legal consultation about your case and to find out more about whether you may be eligible to file a lawsuit, contact the law office of Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001. You can also reach us by following the link to our free case evaluation form and answering a few simple questions about your case to get started.