We all know that surgery can be risky. Patients have the right of informed consent. That means, wherever possible, patients will be given all the information they need to make an informed choice about their care. That includes being told what the risks could be of certain procedures, medical devices and medications.
Johnson & Johnson is being accused of violating patients’ rights in this regard – and flouting federal regulatory procedures – by allowing a subsidiary, Synthes Inc., to market and distribute a type of bone cement to be injected into patients’ spines. This was an off-label use that was not approved by the U.S. Food & Drug Administration (FDA), and the company was well aware of that fact.
And yet, according to a lawsuit underway in Washington state, the company engaged in off-label use marketing to expand its customer base, even though it was understood this product wasn’t approved for use in back surgeries. Patients died on the operating table within minutes of being injected with the compound.
In the case of Wilson et al. v. Chapman, et al., plaintiffs are the survivors of a 67-year-old woman who was supposed to undergo a routine back surgery to treat chronic pain. Her family now alleges the surgeon and the hospital knowingly engaged in off-label use of the material, known as Norian bone cement, even though it was not approved for back surgery use.
The case against doctors, hospitals and the product manufacturers is not an isolated one. Fortune detailed a number of these cases back in 2012. One of those involved a woman whose 83-year-old mother died unexpectedly in spinal surgery. At the time, her daughter didn’t raise too many questions. After all, it’s not unusual for a woman her age to suffer negative side effects during surgery. It wasn’t until years later that an agent with the U.S. Department of Health and Human Services informed her that as a result of its investigation into the company, it was learned the woman’s mother’s spine had been injected with this bone cement. The material was not approved for that purpose, and officials believed it may have played a role in the woman’s death.
Most people have never heard of the company Synthes, which is based in Pennsylvania. But it was the largest acquisition ever by Johnson & Johnson, which paid $20 billion for the company. Interestingly, Johnson & Johnson executives at the time of purchase were praising the culture and values of the company, even as Synthes’ leaders were facing charges of grievous conduct.
The Wilson case is the first civil lawsuit since company executives were sent to prison and the company itself was ordered to pay $23 million in fines.
Attorneys are arguing that the surgeon and a former CEO of Synthes knew the bone cement could be deadly if used in the spine. The material was designed for use in arm and skull bone surgeries. But there were tests on pigs in which the animals died within seconds of the material being injected into their spines. Yet, rather than going through the lengthy – and expensive – process of gaining regulatory approval,, the company decided instead to simply start trying it on humans. The results, as the Wilson case and others have shown, as disastrous.
Our Miami product liability attorneys understand that these companies are alleged to have taken a huge gamble with people’s lives. If those allegations are legitimate, the company needs to be held to account. Plaintiff attorneys are pursuing a product liability lawsuit against the manufacturer and a medical malpractice lawsuit against the surgeon and hospital. J
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J&J Unit Performed ‘Human Experimentation’ With Deadly Bone Cement, Jury Told, June 28, 2016, By David Siegel, CVN
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