Former FDA employees sue agency after personal emails secretly monitored

Feb. 17, 2012 - PRLog -- DePuy ASR hip replacement recall was mentioned once again, in light of a recent lawsuit against the FDA that was brought by a group of the agency’s current and former employees.

The workers claim that the FDA was secretly monitoring their private email accounts after they chose to question certain FDA approvals that they felt might be detrimental to the public.

The plaintiffs claim that the FDA issued warnings or even revoked their contracts when the employees tried to raise concerns about medical drug and device approval. Congress was told by nine doctors and scientists that they were shocked to discover that the FDA had gone ahead and approved the devices that they had researched, despite the researchers’ voiced concerns, and the plaintiffs even went so far as to accuse the FDA of corruption in the way they conduct the device review process.
The way that the FDA approves medical drugs and devices has been under much scrutiny in recent years, as more and more products have been recalled after having caused serious health problems. Take for instance the massive DePuy ASR hip replacement recall from August 2010, when the Johnson and Johnson subsidiary recalled more than 90,000 of the devices in the United States, Great Britain and Australia.

Controversy lies within the 510(k) process, which determines FDA approval based on the similarities between the new product and products that have already been approved, without having to conduct clinical testing. If a device manufacturer can show that the new device is close enough to one of their existing devices, there is a chance that the FDA will approve it through 510(k).

The problem is, however, that even though two products may be similar, there is no guarantee that the new one will be free from health risks, unless the proper clinical tests are performed. In DePuy’s situation, the company sought 510(k) approval by claiming that the ASR was close enough to the already-approved DePuy Pinnacle.
What the company (and the FDA) did not anticipate was the fact that even though the designs of the Pinnacle and the ASR were similar, it would be the difference in material that would cause injury. Unlike the Pinnacle’s ceramic make-up, both components of the ASR are made of metal, and when the parts grind against one another, microscopic pieces of the metal flake off, entering the blood stream and damaging the surrounding tissue.

Thousands of lawsuits against DePuy have been consolidated into Multi-District Litigation, as patients have come forward with failed hips and the need for revision surgeries.  

For more information about the DePuy ASR recall, or any other problems stemming from metal-on-metal hip replacements, contact Zoll, Kranz and Borgess toll-free at 888.841.9623 or via email at Michelle@ToledoLaw.com.

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ZOLL, KRANZ & BORGESS, LLC is an advocate for pharmaceutical drug/device safety and a recognized leader in nationwide litigation involving defective medical drugs and devices, as well as other types of Multidistrict (“MDL”) & Class Action Litigation.