BARTLESVILLE, Oka. — Quick Facts:
Bartlesville man is among thousands of patients pursuing a lawsuit against DePuy over hip implants.
The man says the metal-on-metal device caused metal poisoning -- leading to other health concerns that affected his hearing and vision.
The attorney who won three monetary verdicts in these cases shared some of the evidence with FOX23's Shae Rozzi.
Evidence used in successful trials so far indicates the device maker knew there would be concerns years before recalling one device and deciding not to continue selling another
RECALL: See if your medical device has been recalled: https://www.icij.org/investigations/implant-files/video-how-to-search-the-international-medical-devices-database/
A video from a sales conference shows a company-paid doctor promoting the product as the "Billion Dollar Baby" while encouraging sales representatives to double their sales.
One of the concerns this attorney has is the 510(k) FDA approval process for medical devices which allows device-makers to get approval based on another approved product without testing the new product in any patients before it is sold.
There is a petition to get the "Medical Device Safety Act" passed in an attempt to better protect future patients. Patients will be in Washington later this month pushing for the passing of the Medical Device Safety Act: https://www.petition2congress.com/ctas/the-medical-device-safety-act-hr-2164
CHECK HERE to see if and how much your doctor has been paid by drug and medical device companies: https://openpaymentsdata.cms.gov/
DePuy is part of the Johnson & Johnson Family of Companies and released the following statement:
The FDA released the following statement:
- Medical Device Safety Action Plan and Commissioner's statement about the plan
- REPORT: FDA Has Taken Steps to Strengthen the 510(k) Program - November 26, 2018
- REPORT: CDRH Medical Device Enforcement and Quality Report - November 21, 2018
- Statement from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway
- November 26, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA's 510(k) program to advance the review of the safety and effectiveness of medical devices
- November 27, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway
- December 18, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on new steps to promote innovations in medical devices that help advance patient safety
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