There is a tremendous amount of competition in the world of medical and surgical devices for spinal dysfunction. From back braces to surgical instrumentation used in spinal fusions, every company is trying to get their foot in the door.
One such device is the cement used in the surgical procedures of vertebroplasty and kyphoplasty. In these procedures, a special type of bone cement is injected into the vertebral body that has sustained a compression fracture. This cement must be FDA approved for use in these instances of use.
Risks Of Surgery For Spinal Compression Fractures
Here is a news clip describing the fatal consequences of one company’s attempt to quickly bring their product to market resulting in hefty financial penalties and prison time.
Four former executives of Synthes Inc. have been sentenced to prison for carrying out human medical trials illegally in which three participants lost their lives. US prosecutors had been seeking 1-year prison sentences for “human experimentation”. The four defendants were accused of testing a kind of bone cement, Norian XR, in patients with spine fractures illegally – they had not sought FDA approval for the trial.
Norian XR is only approved for surgical use in the arm, not in the weight-bearing spine.
On passing sentence, the judge called their conduct egregious and said:
“(they showed a) disregard for the safety of others … and for the sanctity of human life.
There’s a perception that this is not the type of conduct that tends to result in a jail sentence. We lose the ability to cause the industry to self-regulate, because the fear of jail for professionals is far greater than the fear of a young drug dealer from the ‘hood’.”
The defendants are:
Michael D. Huggins (former Synthes North America President)
Sentenced to nine months in prison
Thomas B. Higgins (former VP of Berwyn)
Sentenced to nine months in prison
John J. Walsh (former director of regulatory and clinical affairs at Synthes)
Sentenced to five months in prison
Richard Bohner (former VP of Synthes)
Sentencing postponed after his lawyer got ill
Huggins was sent to prison immediately, while Higgins was given two weeks to report to prison; he had some family issues to sort out. Walsh has been allowed to celebrate a child’s birthday and has a week to report.
They all pleaded guilty to a misdemeanor as responsible corporate officers. A misdemeanor is an offence that is lower than a felony and generally punishable with a fine or imprisonment other than in a penitentiary.
The prosecutors say the defendants skirted FDA regulations as they rushed to have the bone cement tested by surgeons. The cement was not approved for people with spine fractures.
Synthes Inc. and Norian Corp. (a Synthes subsidiary) pleaded guilty to corporate health fraud and accepted to pay a fines amounting to $23 million.
However, the defendants say they had not intended to violate FDA procedures. One of the defendants said he made several attempts to make sure the cement was not used off-label.
Higgins lawyer, on Monday, read out a letter written by Higgins, it said:
“I didn’t think at the time that we were doing
U.S. District Judge Legrome D. Davis had not accepted many of the arguments put forward by the defense.
“The patients were directly and proximately harmed by the conduct of defendants and others at Synthes. Defendants subjected the patients to the risks of SRS and XR (bone cement) without the patients’ full informed consent and without the FDA’s authorization. Some of those patients were injured and some died.”
200 spine patients were experimented on with the bone cement. Prior pilot studies had demonstrated that the cement was linked to a risk of blood clots. Animal experiments with pigs showed there was a risk of clots moving to the lungs.
Experts say that in this part of the medical device’s industry, competition is fierce, and the company moved forward recklessly.
Surgeons who operated on the patients who died could neither blame the cement for their deaths, nor exclude them. They had suffered a severe drop in blood pressure after being given the injections. Three of them had already been frail before the trial began.
The prosecutors say the four defendants did not report the deaths, and were not honest with FDA investigators. They were all fired from their jobs and fined $100,000 each.
Even after one patients died in surgery in 2003 in Texas, and a second one died in California, the trial was not halted. The company only stopped the trial after the third death in 2004.
The Judge said:
“One adverse event should have been enough to let you know that this course was not right. I can’t understand how there wasn’t a stop sign”
After the passing of sentences, none of the defendants made a statement in court.
Synthes Inc. is a part of a Swiss-based company with US headquarters in West Chester. Health giant, Johnson & Johnson is acquiring the company for $21.3 billion.
Source: Medical News Today
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Author: Malton A. Schexneider, PT, MMSc