Synthes Indicted Over Unapproved Study of Bone Cement

[hospo007]

From OutpatientSurgery.net:


Federal indictment alleges that bone filler was used in spine surgeries without FDA authorization.

Synthes, the world's largest maker of implants to mend bone fractures, conducted an unapproved study of the use of its Norian XR injectable cement bone filler that led to the deaths of 3 patients during spinal surgery and then lied to the FDA about it, prosecutors said yesterday after a federal grand jury in Philadelphia handed down a 52-count indictment.

Prosecutors allege that between 2002 and 2004, Synthes and its subsidiary, Norian, conspired to conduct unauthorized clinical trials on 2 versions of the product in spinal surgeries to treat vertebral compression fractures — an application of the bone filler explicitly prohibited by the FDA, according to a published report. The 3 patients who allegedly died during the trials died from rapid drop in blood pressure. The company marketed the cement for spinal fractures even after pilot studies showed it caused blood clots that could become lodged in the lungs, prosecutors said.

"Synthes has fully cooperated with the government’s investigation," and "believes that its marketing practices in connection with Norian XR were proper," a Synthes spokesman says in a statement. Synthes "intends to vigorously defend itself against the charges," he said.

The indictment includes 52 felony counts against California-based Norian, 44 misdemeanor counts against its Switzerland-based parent company, Synthes Inc., and 1 criminal misdemeanor count each for 4 Synthes executives accused of shipping an adulterated and misbranded product.

The indictment also accuses the companies of "allegedly carrying out a cover-up in which they lied to the FDA during an official inspection in May and June 2004." In a statement, U.S. Attorney Michael Levy says the companies and executives "put their profits ahead of responsible business practices and the truth."

Synthes, with North American offices located in West Chester, Pa., acquired Norian in 1998. If found guilty, Norian could face $28 million in fines; Synthes could face $8 million in fines; and the 4 executives charges could face 1-year prison sentences.

—Irene Tsikitas

[mmglobal]

If what's said in the story is true... jail time seems appropriate. Again, if true... 1 year seems inadequate.

Mark

[nomorepain]

I have to agree, 1 year isn't enough! Wow is about all one can say, after the housing and financial scandals, where GREED seems to be at the top of the list, this is high up in my eyes. These people should be hung out to dry!
geeeeeze

[catherine K]

I also was in the last group of Dr. Delemarters two level trial studies.
Unlike you~ I am not a post person. Something just didn't work. Things went wrong.....right from the start. I believe the disc were put in correctly, something just wasn't right. And after one yr of pain, I was booted from the trial study. I had heard,( from staff in the office)~ that men's spine's were better able to support the weight of the ADR's. And women, especially I guess if they have a weaker spine, can't support them. Which is what happened with my spine.
I am so very glad that you are pain free......and I only wish for days where maybe I can get 5 minutes or 10 minutes of relief.
Remember to enjoy every moment!

[Dulishun]

The only thing on that is that they were indicted over another product, bone cement, not artificial disks. Terrible to hear yours did not go well. What did they tell you?