New FDA Rule May Allow Defective Device Manufacturers to Delay Reporting Problems

By S. Randall Hood | July 21, 2017

New FDA Rule May Allow Defective Device Manufacturers to Delay Reporting ProblemsEvery five years, the Food & Drug Administration and medical device manufacturers renegotiate a deal regarding the costs of reviewing medical devices. The newest negotiation would allow manufacturers to potentially report malfunctions in their products 4 times a year, as opposed to every month. From the New York Times:

“The current draft compels the F.D.A. to speed medical devices onto the market — and into patients — faster than ever. But, at a time when the F.D.A. acknowledges that medical device mishaps are vastly underreported, a provision in the bill says the agency should permit companies to report malfunctions every three months, rather than the current practice of submitting reports within 30 days of a problem.”

Patient advocates are up-in-arms about the change, stressing extensive underreporting, as well as the increased number of defective products which did not present with issues right away. Among those types of defective medical products were:

  • Power morcellators
  • Transvaginal mesh
  • Cardiac defibrillators
  • Duodenoscopes
  • Breast implants
  • Medtronic Infuse bone grafts

McGowan, Hood, Felder & Phillips, LLC has earned a national reputation for its aggressive, comprehensive litigation of complex cases involving defective medical devices and dangerous drugs. From our offices in North and South Carolina, our attorneys have fought on behalf of countless patients and their families. Please call 803-327-7800, or fill out this contact form to speak to a member of our team about your case.

 

Posted in Medical Devices