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

If you have been a victim of a traffic accident, call Chalik & Chalik at (954) 476-1000 or 1 (800) 873-9040.

Additional Resources:

J&J Unit Performed ‘Human Experimentation’ With Deadly Bone Cement, Jury Told, June 28, 2016, By David Siegel, CVN

More Blog Entries:

Tarvin v. CLC of Jackson – Nursing Home Arbitration Agreement Nixed, July 2, 2016, Miami Product Liability Lawyer Blog

Why would anyone agree to such a system? The truth of the matter is, most people don’t realize they are. The agreement is often stuffed in a mountain of admissions paperwork right when they are first signing in – an overwhelming experience as it is.

Although courts do recognize the validity of such agreements as binding contracts, there have been an increasing number of cases in which courts have decided these agreements violate public policy or for other reasons are not valid. The recent case of Tarvin v. CLC of Jackson is one of those. This was a case recently weighed by the Mississippi Supreme Court, but the legal principles are still relevant to those of us here in Florida.

According to court records, plaintiff’s father, decedent, was admitted to defendant nursing home in August 2007. Plaintiff, his daughter, signed the admission agreement on his behalf as his “responsible party.” Two other family members also signed the agreement as “family members,” but the patient himself did not sign the document. Among the many terms and conditions of his admission was an arbitration agreement.

He lived at the facility for more than three years. Then in January 2011, he was rushed to the hospital when staff discovered numerous life-threatening sores all over his body. Despite receiving treatment at the hospital, patient died in May 2011.

Pressure sores are one of those kinds of nursing home injuries that should just never happen. They are caused by a person sitting or laying in one position too long without being cleaned or turned.

Plaintiff as representative of decedent’s estate filed a wrongful death lawsuit against the nursing home alleging her father had suffered serious nursing home abuse and neglect that resulted in weight loss, malnutrition, dehydration, skin tears and of course, the sores.

Defense in its response moved to compel arbitration. Attached in its motion were documents indicated that decedent’s doctor, prior to his admission, wrote in medical records that he was “obviously demented at this time.”

Plaintiff responded that first of all, the company waived its right to compel arbitration because it participated in litigation. But beyond that, she had no legal authority to bind her father to that arbitration agreement. She was not his listed power of attorney or conservator.

Trial judge upheld the motion to compel, citing the patient’s doctor’s report indicating he did not have the legal capacity to sign on his own behalf. Plaintiff countered that the physician’s notes were based on the doctor’s observations that her father was disoriented, but there was never a diagnosis made with regard to his mental state.

Plaintiff appealed to the state supreme court, arguing no valid arbitration agreement exists. The state supreme court agreed. The court ruled the Uniform Health Care Decisions Act requires a finding by a primary physician that a person lacks capacity before a surrogate can be assigned to make health care decisions for that person. The record here didn’t support that finding. The court remanded this case back to the lower court for trial.

If you have been a victim of a traffic accident, call Chalik & Chalik at (954) 476-1000 or 1 (800) 873-9040.

Additional Resources:

Tarvin v. CLC of Jackson , June 23, 2016, Mississippi Supreme Court

More Blog Entries:

Enrique v. State Farm – Bad Faith Insurance Lawsuit, June 24, 2016, Miami Nursing Home Abuse Lawyer Blog