Former Synthes Execs Jailed For Fatal Clinical Trial

Former Synthes Execs Jailed For Fatal Clinical Trial

November 22nd, 2011 // 2:24 pm @ jmpickett

Three executives from Synthes, a device maker that was recently purchased by Johnson & Johnson, were sentenced yesterday to prison for their roles in an unapproved trial of a bone-cement drug that led to three patient deaths. A fourth exec will be sentenced later. All four pleaded 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, will be sentenced at a later date. Each must also pay a $100,000 fine.

The outcome is unusual in that this 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 (you can read it here).

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.”

“When corporate executives authorize clinical trials of a medical device without the FDA’s permission and without regard for known safety risks, including death, those executives must be held accountable,” US Attorney Zane David Memeger says in a statement. “…They subjected frail and elderly patients – among the most vulnerable members of our society – to serious safety risks. (The) sentences should clearly put health care industry executives on notice that when they violate the law and harm individuals for the sake of corporate profits, they will go to prison.”

The Norian subsidiary, by the way, pleaded guilty to one felony count of conspiracy to “impair and impede the lawful functions” of the FDA and commit crimes against the US, as well as 110 misdemeanor counts of shipping adulterated and misbranded Norian XR in interstate commerce. The parent company, Synthes, was charged with one misdemeanor count of shipping adulterated and misbranded Norian XR in interstate commerce.

Earlier this year, Johnson & Johnson paid $21.3 billion deal to buy Synthes in a bid to gain a market-leading position in trauma products and become a dominant player in the $30 billion orthopedic market .

Source: Pharmalot