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

As The New York Times reported in-depth on the issue in 2007, these facilities have worked to structure ownership in ways that separate real estate and investment from operations, in many cases resulting in several distinct sub-companies having their hand in the pot – but all denying responsibility when a patient suffers illness or injury due to nursing home neglect or abuse. As the U.S. Department of Health and Human Services put it, “Knowing the proprietary status of a nursing home provider is insufficient to discern how organizational assets are structured and the operational approach of the company managing the delivery of nursing home services.” DHHS research showed nursing home are increasingly outsourcing management companies to deliver care to residents.

An example of how this can complicate a nursing home neglect lawsuit was seen recently in the Oklahoma Supreme Court case of Maree v. Neuwirth. According to court records, decedent was a resident of defendant nursing home facility when in January 2011, she suffered a fall. Plaintiff, decedent’s daughter, alleges her mother fell because defendant nursing home failed to respond to a “call light” in a timely manner in order to provide the elderly woman with appropriate toileting help. On top of that, the nursing home reportedly failed to contact a doctor or other appropriate medical assistance in a timely manner. Seven hours passed before a physician was called. Two days after the fall, patient died. 

Two years after decedent’s death, plaintiff filed a lawsuit, asserting her mother’s injury and death were the result of nursing home negligence. Plaintiff cited as defendant the nursing home, corporately and/ or by and through its servants, agents and employees, as well as the owner/operator. She alleged the nursing home breached its contract with the state by failing to comply with federal and state laws regarding long-term care, with decedent being the intended third-party beneficiary of those regulations.

Then in November 2015, almost five years after decedent’s death, plaintiff filed a motion to amend her petition to include “certain individuals and entities intertwined amongst and actually part of the named defendant.” She alleged these individuals made important decisions concerning staffing, hiring, budgeting, personnel issues, procedures and policies – including safety measures and directives regarding patient care and supervision.

Nursing home objected to motion to amend, arguing the the statute of limitations precluded claims against other entities and individuals, petitioner caused undue delay that was prejudicial to nursing home and the amendment doesn’t relate back to the original petition. Trial court denied the motion to amend based on the statute of limitations, and the fact that the conduct alleged by plaintiffs was not in connection with or directly involved with the occurrence of the action as originally filed.

Plaintiff appealed to the state supreme court.

The court ruled the trial court failed to afford petitioner the opportunity for discovery of her claims before deciding the issue on its merit. Thus, the court determined the trial court reached that conclusion in error and granted a writ of prohibition blocking the trial court from preventing that order. With regard to the writ of mandamus to allow plaintiff to amend the complaint, the trial court remanded for further consideration in light of the opinion.

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

Additional Resources:

Maree v. Neuwirth, June 7, 2016, Oklahoma Supreme Court

More Blog Entries:

Florida Day Care Injuries Give Rise to Lawsuit, May 25, 2016, Miami Nursing Home Abuse Lawyer Blog

If you filed a claim for survival damages, or the wrongful death lawsuit or statute permits you to recover medical expenses, then the Medicare lien is required to be paid from the settlement proceeds. But if your claim was filed only for the decedent’s wrongful death, and not for the right to seek reimbursement of medical expenses, then the Medicare lien does not have to be paid from the proceeds of the wrongful death settlement.

The Department of Health and Human Services manages the Medicare program, which was established to pay the medical expenses of certain people. If a Medicare recipient was injured by a third party, then any payment by Medicare to cover the recipient’s medical bills is considered provisional, and Medicare must be repaid if the third party’s liability insurer subsequently pays for those expenses.

In Hall v. United Security, 2012 IL App (1st) 112158-11, the defendants made a motion to include Medicare as a payee on the check in settlement of a wrongful death action. The lawsuit did not consist of a claim covered by the Illinois Survival Act, and the trial court sided with the plaintiff. Upon filing an appeal, the defendants contended that exclusion of Medicare from the settlement check left them susceptible to a lawsuit from the federal government for funds expended by Medicare for the decedent’s medical expenses. But the Appellate Court declined to accept the defendants’ contention.

At first, the court recognized the difference between a claim filed under the Survival Act, and one filed under the Wrongful Death Act. The court determined that the Illinois Wrongful Death Act permits damages to be recovered only when they were sustained by the closest family members while the Illinois Survival Act allows damages to be recovered only when they were suffered by the decedent until the time of death.

The court said that the plaintiff’s complaint consisted only of claims for wrongful death, and that the damages that could be recovered were only those based on financial loss to the decedent’s survivors. Because the claims of this action were not ones for financial loss, damages and pain and suffering of the decedent, there were no claims to which the Medicare lien applied. Therefore, when a plaintiff’s complaint seeks damages only for the decedent’s wrongful death, Medicare does not have to be reimbursed for payment of the decedent’s medical expenses.

Paul Greenberg is a Chicago wrongful death lawyer with Briskman Briskman & Greenberg. To learn more call 1.877.595.4878 or visit http://www.briskmanandbriskman.com/.

If you filed a claim for survival damages, or the wrongful death lawsuit or statute permits you to recover medical expenses, then the Medicare lien is required to be paid from the settlement proceeds. But if your claim was filed only for the decedent’s wrongful death, and not for the right to seek reimbursement of medical expenses, then the Medicare lien does not have to be paid from the proceeds of the wrongful death settlement.

The Department of Health and Human Services manages the Medicare program, which was established to pay the medical expenses of certain people. If a Medicare recipient was injured by a third party, then any payment by Medicare to cover the recipient’s medical bills is considered provisional, and Medicare must be repaid if the third party’s liability insurer subsequently pays for those expenses.

In Hall v. United Security, 2012 IL App (1st) 112158-11, the defendants made a motion to include Medicare as a payee on the check in settlement of a wrongful death action. The lawsuit did not consist of a claim covered by the Illinois Survival Act, and the trial court sided with the plaintiff. Upon filing an appeal, the defendants contended that exclusion of Medicare from the settlement check left them susceptible to a lawsuit from the federal government for funds expended by Medicare for the decedent’s medical expenses. But the Appellate Court declined to accept the defendants’ contention.

At first, the court recognized the difference between a claim filed under the Survival Act, and one filed under the Wrongful Death Act. The court determined that the Illinois Wrongful Death Act permits damages to be recovered only when they were sustained by the closest family members while the Illinois Survival Act allows damages to be recovered only when they were suffered by the decedent until the time of death.

The court said that the plaintiff’s complaint consisted only of claims for wrongful death, and that the damages that could be recovered were only those based on financial loss to the decedent’s survivors. Because the claims of this action were not ones for financial loss, damages and pain and suffering of the decedent, there were no claims to which the Medicare lien applied. Therefore, when a plaintiff’s complaint seeks damages only for the decedent’s wrongful death, Medicare does not have to be reimbursed for payment of the decedent’s medical expenses.

Paul Greenberg is a Chicago wrongful death lawyer with Briskman Briskman & Greenberg. To learn more call 1.877.595.4878 or visit http://www.briskmanandbriskman.com/.

Sylvia Burwell, the Secretary of Health and Human Services, said that the proposed changes set high standards for safety and quality in nursing homes. The proposals were announced as part of the White House Conference on Aging.

Some of the proposals address nursing home abuse. Nurses would be required to be trained in dementia care and preventing elder abuse. There will also be a requirement that nursing homes report staffing levels, which Medicare officials will review to determine whether they are adequate. This stops short of requiring a federal nurse-to-resident ratio, which many advocates had pushed for. Dr. Shari Ling, the deputy chief medical officer for Medicare, said the administration’s approach focused on competency rather than “a numbers game.”

The proposed changes include measures to ensure that families are more involved in the care of their loved ones, as well as rules to promote more individualized care. For instance, residents would be able to choose their own roommates, and requests for meals and snacks at non-traditional times would be accommodated. The proposed rules also address reducing hospital readmissions, minimizing the use of antipsychotic drugs and antibiotics, and strengthening infection control.

If you suspect that a loved one has been abused or neglected at a nursing home, contact Joyce & Reyes for a free consultation to learn more about your rights.

If you need to speak with a Tampa nursing home abuse lawyer, Call Joyce & Reyes at 1.888.771.1529 or visit more of http://www.joyceandreyespa.com/.

Details of the Case

The case involved the care of Betty Jensen, a dementia patient. Her son, Jason Jensen, determined that she could benefit from the help of a caregiver. He hired a non-relative, paying her $19,000 over many months. However, the Jensen’s did not sign a formal agreement with the caregiver nor did they get a direct order from a doctor recommending the service. When Ms. Jensen’s condition worsened, she was admitted into a nursing home and applied for Medicaid to cover the costs. However, the state said her coverage would not be applied until after a penalty period because the money paid to the caregiver was considered a divestment, or unlawful transfer because it was not a formal, contracted arrangement. Sadly, Ms. Jensen passed away before this penalty period was up.

Court Rulings

At first, a trial court sided with the Jensen’s, reasoning that contracts were only required when the caregiver was a relative. However, when the state appealed, the Michigan Court of Appeals reversed the decision and said the penalty period was appropriate in this case. Their decision hinged on the regulation that says payments to caregivers are considered divestments, unless there is a signed contract and a recommendation from a doctor.

What is a divestment? Generally speaking, it’s the opposite of an investment. Companies or individuals that take action to reduce assets are considered divesting. In the business world, companies may do this just before selling to another firm to lower their net worth. As far as Medicaid is concerned, individuals that dispose of their assets for an amount that was less than fair market value are considered divesting and are subject to a penalty period when Medicaid benefits will be withheld. Medicaid has the right to look through financial transactions for the previous five years to determine if the penalty period is applicable. How long is the penalty period? It depends on the amount of the assets divested, and there is no limit to the penalty period. For example, Ms. Jensen paid her caregiver $19,000. The amount of Medicaid that will be withheld is the average amount that would be paid for a monthly private-pay rate at the nursing home. If the nursing home costs $3,000 per month, the penalty period would be about six and a half months ($19,000/$3000).

Lessons Learned

Regulations do not bend for personal circumstances. The state court admitted, “If we were not bound by the plain language of [the regulations], and were we permitted de novo review of the lower tribunals’ factual considerations, we would reach quite a different result.” The judge did not think Mr. Jensen hired the caregiver unnecessarily or overpaid for the services. They were legitimately needed. However, they are bound to uphold state law.

The biggest lesson here is that elder care requires strategy and planning. In order for your loved ones to receive the Medicaid benefits they deserve and protect their hard-earned assets, family members need to know the laws and regulations in their state. Being caught off guard may result in patients having to absorb large out-of-pocket costs. The Elder Care Firm specializes in helping families plan for the best quality of life for their loved ones. Consult one of our attorneys to discuss how to qualify for Medicaid benefits and how best to protect your family’s assets. Contact us for a consultation.

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