Sunday, August 26, 2012

FDA: J&J Unit (Synthes) Recalls Potentially Flammable Bone Putty

The health regulator said certain lots of bone putty made by Johnson &Johnson unit Synthes were recalled as there was potential for the putty to catch fire if it came in contact with electrosurgical cautery systems during surgery.

The Hemostatic Bone Putty is used to stop bone bleeding by creating a physical barrier along the edges of bones damaged by trauma or cut during a surgical procedure.
The recall, which has been classified as Class I, or the most serious type of recall, was initiated on July 5.
Synthes had issued a medical device recall letter on July 5 requesting medical facilities to examine their inventory and immediately stop using the identified part and lot numbers of the putty manufactured between July 6, 2011 and December 14, 2011.
Synthes has been in the news for all the wrong reasons, Symthes is unusual in that it is one of a few cases in which company execs have been sentenced to a term of imprisonment for a misdemeanor violation of the Food, Drug and Cosmetic Act. The individual defendants, by virtue of their jobs, were “responsible corporate officers” at various time during the circumstances surrounding the clinical trial that was described in the indictment.

And what exactly took place? From May 2002 until fall 2004, a Synthes subsidiary called Norian, as well as Synthes and the former execs, ran unauthorized trials of their Norian XR and Norian SRS devices, which were bone cements used in surgeries to treat vertebral compression fractures of the spine, or VCR, a painful condition commonly suffered by the elderly, according to the feds.

The surgeries were performed despite a warning on the FDA labeling for Norian XR that cautioned against this use, and in the face of serious medical concerns about the safety of the devices when used in the spine, according to the feds. But they apparently disregarded the warnings. For instance, the feds say that, before the marketing program began, pilot studies showed the bone cement reacted chemically with human blood in a test tube to cause blood clots. The research conducted in a pig also showed that such cement-caused clots became lodged in the lungs.

Just the same, the Synthes gang marketed the device for VCFs without conducting testing that needed FDA approval, the marketing did not stop until after a third patient had died on the operating table.The trials were conducted at various US hospitals and selected surgeons were approached during so-called ‘Test Market Kick-Off’ meetings and a forum in 2003 and early 2004, according to the feds, who say about 52 spine surgeons were trained.

What’s more, after the death of that third patient in January 2004, they did not recall Norian XR from the market – which would have required them to disclose details of the three deaths to the FDA, according to the feds. Instead, they “compounded their crimes by carrying out a coverup in which they made false statements to the FDA during an official inspection in May and June 2004.” However since the purchase by J&J, it is J&J who now hold the legal burden.

To date:
2011 - Three executives from Synthes, a device maker that was recently purchased by Johnson & Johnson, were sentenced to prison for their roles in an unapproved trial of a bone-cement drug that led to three patient deaths. All four plead guilty to one misdemeanor count of shipping an adulterated and misbranded product in interstate commerce.Thomas Higgins, 55, a former president of the Synthes spine division, and Michael Huggins, 54, a former president of Synthes North America, were each sentenced to nine months. John Walsh, 48, who was director of regulatory and clinical affairs, was sentenced to five months. Richard Bohner, 57, sentenced at a later date to 8 months. Each must also pay a $100,000 fine. 
Feb, 2012 - FDA Warning Letter 
Latest 2012 - FDA: J&J Unit Recalls Potentially Flammable Bone Putty

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