When A Medical Device Company Crosses the Line Into Crime
June 7th, 2013 // 10:25 pm @ jmpickett
Latest FDA and cGMP Compliance News
Most of the time, when the Office of Criminal Investigation (OCI) at FDA gets involved in a case, it results in criminal and civil penalties. Recent examples include Abbott Laboratories and Amgen, where they both paid into the billions of dollars in fines to the US government.
However, at times the conduct of some drug and device firms is so bad, that criminal prosecutions are needed.
Download Your Free Sample – the Latest FDA 483 and Warning Letter Reports!
One of the cases that our contacts at FDA still talk about is when OCI worked on the Synthes case, which marketed a bone cement product by the name of Norian WR. This product was approved by FDA to be used in some cases, but it was rejected to be used as an injection into the spinal column in a mixture. This is what Synthes wanted to use it for.
The label that was approved by FDA actually warned against using it in this way. Rather than attempting to get the agency to approve it through clinical trials, which would have cost about $1 million and took about 36 months, Synthes had doctors do the procedure and then publish what happened, no matter what the risks were.
Synthes knew what the risks were; a pilot study by the company showed that the bone cement could react chemically with human blood and cause blood clots. Research showed that in pigs, the cement could cause clots that lodged in the lung.
Still, the Synthes execs went ahead and did an essentially unapproved clinical trial for Norian to be used on vertebral compression fractures. The company actually marketed the product that went against the Black Box warning, which is the most serious warning that FDA can issue.
As you can guess and may already know, the results were tragic.Three patients who were injected with the bone cement died during surgery. Still the firm did not do a recall. This would have mandated that the company disclose the details of the deaths to the agency. Also, the officials at Synthes misled FDA auditors during an inspection in 2004.
A long criminal investigation was initiated by OCI, who worked with the Office of Regulatory Affairs and officials and scientists at CDRH. Synthes eventually pleaded guilty and paid $23 million in fines. In 2011, four of the executives were sentenced and put in prison.
Another tragic case worked on by OCI was with Apothecure, which was a compounding pharmacy in Dallas that sent colchicine injectable solution to medical centers in Oregon. Colchicine can be used to stop attacks of gout and to cut the pain of gout attacks. But in 2007, three patients who received the drug died within hours.
FDA did tests of some of the vials of the drug. They showed to be super potent, with over 600% of the drug that was on the label. Some were subpotent with less than 63% of the amount on the label. The pharmacy and the owners pleaded guilty to criminal charges last year. They also did jail time.
OCI’s work won’t bring back the lives lost, but there is no doubt that their determined work serves as a deterrent to drug and device companies who are thinking about crossing the line into criminal activity.
