An expert witness report from a Duragesic lawsuit explains why so many Duragesic fentanyl patches from 2003 and 2004 had safety problems. Apparently, the problem was that employees were expected to visually inspect 240 patches per minute. I’ve written about that before. What I just discovered was that as early as March of 2002, there was an electronic quality control system available that supposedly could have eliminated the need for employees to visually inspect the patches:
11. Do the batch records and documents demonstrate that the defendants failed or refused to take appropriate and necessary corrective and preventative action to ensure that the Duragesic patches released to consumers in 2003 – 2004 periods were safe?
Rationale: The company knew that there were critical defects present in the product that were inherent to, and directly traceable to, the design of the product, yet they produced and released product for years without changing the design to assure that the product was safe. The company knew that the production process was incapable of consistently producing product but they kept trying to minimize the problems by inspecting and segregating pockets of each lot rather than stopping production and re-designing the process.
FDA would term the company’s actions, as they have in similar situations with many other companies, as "testing into compliance" – repeated testing of the product until a satisfactory test result is obtained. Further, according to the company’s qualification report (DUR2 082575) dated March 2002, the company had available a qualified "Electronic Vision Inspection System" that could have been used to detect critical patch defects. For reasons that cannot be ascertained from the evidence made available to me, this device was not in operation during this time period, and not in operation for this specific batch of Duragesic.
Untrained operators were required to perform visual inspection of patches as they exited the Bodolay machine at a speed of 14,400 units/hour (equivalent to 240 patches exiting the machine each minute). The electronic vision inspection system was designed (DUR2 082576) to 100% inspect, detect, and reject patches with:
¯ Seal flaws, including gel within the seal
¯ Seal width within tolerance limits
¯ The presence of gel within the system
In my opinion, if the electronic vision system had been used during this time, and in particular for the manufacture of 0327192, it is likely that the widespread and obvious defects leading to the company’s recall of Duragesic patches would have been caught during manufacture and defective patches, rejected, and hence not released to market.
I know that at some point in time the company did implement the “Electronic Vision Inspection System,” but I don’t know how effective it has been in spotting defects like the “classic stringer leaker” and other common defects with Duragesic patches. Considering that each defective patch can lead to a wrongful death, I hope the new system is really 100% effective. Otherwise, there will be more Duragesic lawsuits filed.
Here’s a link to more information about this expert report, including the full report in PDF format.