CNNMoney describes the chilling details of the bone cement horror stories surrounding the medical device company Synthes.
In 2009 the U.S. attorney in Philadelphia accused the medical device manufacturer of running illegal clinical trials — essentially, experimenting on humans. Between 2002 and 2004, Synthes tested a product called Norian XR, a cement that has a unique capacity to turn into bone when injected into the human skeleton. The Food and Drug Administration explicitly told Synthes not to promote Norian for certain spine surgeries, but the company pushed forward anyway.
The surgeries, known as the vertebroplasty project, resulted in the death of at least five patients who had Norian injected into their spines.
The indictment of Synthes and its executives shook the health care industry. This is a story about a company that repeatedly ignored evidence of potential lethal consequences. Interviews with more than 20 former employees and surgeons involved in the Norian project, hundreds of pages of court transcripts, and company documents submitted in the case reveal that Synthes not only disregarded multiple warnings that it was flouting the rules, but also brushed off scientists’ cautions that the cement could cause fatal blood clots.
The Department of Justice targeted four high-ranking executives, all of whom pleaded guilty to a misdemeanor under an unusual provision of health care law called the Responsible Corporate Officer Doctrine. They accepted responsibility for the company’s crime of running unauthorized clinical trials and for engaging in off-label marketing, or promoting products for unapproved uses, without conceding that they were involved in the crime. At the time, no executive had ever gone to prison for such a charge.
Although off-label marketing has become increasingly popular, this wasn’t the typical off-label marketing case. Nor was it typical of trials for medical devices or drugs. Patients sometimes die during such clinical trials — but only after being advised of the risks and then granting their consent. In hiding the unapproved status of the cement, prosecutors argued, Synthes denied patients the right to choose whether they wanted to be test subjects.
For the Justice Department, the Synthes case posed an unprecedented opportunity. It could finally hold individual businessmen accountable for their actions. Mary Crawley, the assistant U.S. attorney who led the prosecution, urged the court to send the executives to jail for their “venal crime.” The “callous disregard of patient safety,” she argued, “warrants the highest sentence the law will allow.”
It took nearly five years of FDA proceedings, investigation, and grand jury hearings before federal prosecutors were ready to move forward with their case. By 2009 they were prepared to indict not only Synthes but also four individuals: Huggins, Higgins, Bohner, and Walsh. The executives’ attorneys negotiated a deal in which the men would plead guilty to a misdemeanor under the Responsible Corporate Officer Doctrine. The U.S. Supreme Court has ruled that the Food, Drug, and Cosmetic Act allows prosecutors to charge individuals who lack actual knowledge of a crime simply because they are “standing in a responsible relation to a public danger.”
On June 16, 2009, the grand jury handed up an indictment against Synthes and the executives. It was a doozy. Norian, the company, was charged with 52 felony counts, including lying to the FDA and intent to defraud. Synthes, its corporate parent, was charged with 44 misdemeanors. Though the U.S. attorney’s office charged the four businessmen with just a single misdemeanor for their roles as “responsible corporate officers,” it outlined in excruciating detail the history of the Norian XR test market and deaths. The U.S. attorney’s office issued a press release peppered with lurid details, including the allegations that Synthes had performed “human experimentation.”
In Nov. 21, 2011, the four Synthes executives appeared for sentencing in a federal courthouse in Philadelphia. Huggins received nine months in jail, as did Higgins. Bohner was sentenced to eight months and John Walsh was given five months. These sentences resulted in the first time ever executives were sent to jail. Most people expected the four executives to receive fines, or possibly probation.
This terrible story of horror and tragedy is still being written as for the victims already identified, justice has not yet fully been served as their families are awaiting settlements for the lawsuits they filed on their patients’ behalf.[hr]