The International Consortium of Investigative Journalists announced on March 27, 2019 that the Food and Drug Administration (FDA) will soon correct a major flaw its disclosure systems. The FDA had, for nearly 20 years, given manufacturers of medical devices the ability to file quarterly reports of incidents to the FDA in a secret “alternative summary reporting” database. About 100 medical device manufacturers took advantage of this private database to prevent disclosure of lawsuits and other claims against the device makers.
It was bad enough that consumers didn’t have access to the millions of records of patient harm and malfunctions. What made the regulation opening the reporting to the public essential was that doctors and hospitals didn’t have knowledge of the medical device defects either. Doctors were unknowingly using medical devices during surgeries and for implants that they reasonably thought were safe – when the manufacturers and the FDA knew they weren’t.
The FDA has argued that the alternative summary reporting database was needed to balance the rights of patients with the desire expressed by manufacturers that they couldn’t afford to design new products if all reports of defects were available to everyone.
The Commissioner for the FDA announced the new policy after the ICIJ had “reported that hundreds of thousands of incidents related to breast implants had been kept out of public sight under the summary reporting program.” The ICIJ study was based on a report by Kaiser Health News which disclosed that more than 1.1 million breast implant incidents had been kept private since 2016. The breast implant failures were causing numerous complications including a rare form of cancer.
A former FDA analyst who created “Device Events, a database that tracks medical device adverse events data,” said the failure to disclose the breast implant incidents has done a great disservice to patients and health providers.
As a result of the ruling, the FDA will release past summary reports and future summary reports. The FDA will still allow manufacturers to avoid disclosing individual incidents. A condensed summary will still be allowed. The FDA will also release summary reports of medical device malfunctions that don’t harm patients but are device errors.
Medical device lawsuits
When medical devices cause harm to patients, the harm can be quite severe. Some failures can be life-threatening. Other failures can cause a lifetime of pain. Often corrective surgery is not possible. When corrective surgery is available, patients should still be compensated for all the physical pain between the first surgery and the second surgery and all the emotional stresses during that time-period as well.
Manufacturers and sellers of defective medical devices can be held strictly liable if their device is defective and the defect causes a patient harm or causes a patient to die.
At Delius & McKenzie, PLLC, our Sevierville product liability lawyers fight for patients and consumers who suffer harm due to faulty products. We file wrongful death actions on behalf of families when a defective product tragically takes the life of a family member. We work with product safety professionals to prove medical devices and products are defective. If you or a loved one was harmed by any product in Sevierville, Seymour, Gatlinburg, Pigeon Forge, or the surrounding Tennessee areas, our lawyers are ready to help. Please call us at (865) 428-8780 or use our contact form to speak with our experienced product defect lawyers.