Smith & Nephew BHR – How can a device manufacturer be denied by the FDA on a 3/2 vote in 2004 and then in 2006 be approved by a 3/2 vote using the same data ?
Smith & Nephew were denied approval of their BHR system by the FDA because their application relied on a single patient group of 2,385 controlled by the partial inventor of the BHR, who worked for the company and financial interest that exceeded the $25,000 limit for an employee to receive as a bonus for his partial invention (the package he received was a reported to be $191 million dollar value).
The concern expressed by the FDA in 2004 revolved around the lack of data concerning metal particles entering the human body and the adversities that could take place.
Then 2 years later Smith & Nephew applied to the FDA using the same information, BUT if the information I have is correct, McMinn was this time “an advisor and not an employee”. It appears this was sufficient to distance him from the company and satisfy the FDA’s requirements?
The BHR information provided still came from one test group. McMinn responded that 140 surgeons in 23 countries were using the bHR, none in the USA. It seems that this information was never checked (who will ever know), and that the FDA excepted the word of one person, and that person is reported to have had financial benefits to the tune of $191 million. Perhaps he should pay for our suffering from his earnings?
Something smells. Now there are 1000’s of innocent people suffering all around the world because of this BHR device and in the USA the manufacturer gets to hide behind the PMA law.
This same company (Smith & Nephew) continues to have brushes with the law and seems to be establishing repeat offender status: part of the group of medical device manufacturers who settled multimillions for paying surgeons kick backs and now they are being sued in a USA whistleblower case, involving fraudulent billing.
We need to get on this as much as possible and as quick as possible before they pass the health reform bill. I fear your country and others will follow suit of the USA and Smith & Nephew will never be called to account financially.
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