A new pill with old ingredients is being pushed to nursing homes and their patients, despite documented reports of side effects ranging from dizziness and falls to death. The medication is Nuedexta from Avanir Pharmaceuticals, Inc. Nursing homes often call it “The Little Red Pill.” Some doctors appear to be illegally profiting from Nuedexta, and tax dollars are frequently paying for it.

What is Nuedexta?

Nuedexta combines two old, well-known drugs: dextromethorphan and quinidine. If you’ve ever taken over-the-counter cough syrup, you’ve likely taken dextromethorphan, a cough suppressant. Quinidine is less commonly taken; doctors prescribe it to treat certain types of heart arrhythmias (irregular beats) and, in some cases, malaria. When you combine the two, the result is a drug that is effective in combating pseudobulbar affect (PBA), characterized by uncontrollable crying or laughing. Persons diagnosed with multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, can suffer from PBA, which is found in less than one percent of the U.S. population.

Why Use Nuedexta?

Because Nuedexta has a psychotropic effect, nursing homes find it useful to control certain behaviors of those with Alzheimer’s disease or other dementia disorders. Patients with dementia often need additional hours of nursing care. Previously, the solution was either to hire more staff or choose not to provide sufficient care for the patient. When a drug is used, patients are quieter and the cost to the nursing home is much smaller, because Medicare Part D picks up some of the costs. Drugs cost less than extra staff.

An Avanir website claims PBA is a problem for 40 percent of dementia patients. But doctors who specialize in treating the elderly and dementia researchers say that PBA is actually quite rare in dementia patients, affecting at most 5 percent of them.

Clinical Trials

The clinical trials required for FDA approval were done only with MS or ALS sufferers, and not those with Alzheimer’s disease or other dementia disorders. In fact, the drug has not been well-studied for use in the elderly. Avanir conducted only one double-blind study, with 194 Alzheimer’s patients, and discovered that those taking Nuedexta suffered from falls at greater than twice the rate of those taking the placebo.

Harmful Evidence

Voluntary reports sent to the FDA by caregivers have indicated that Nuedexta potentially causes a number of side effects and actual harm to the patient. The reports have listed the following events:

  • 51 deaths
  • 113 hospitalizations
  • 102 cases of sedation and sleepiness
  • 101 cases of dizziness, confusion, and falls.

One report to the FDA told the story of an 86-year-old Alzheimer’s patient’s rapid decline and subsequent death after taking Nuedexta. In the words of the nurse-practitioner who filed the report, “The patient seemed to be doing fine until she was placed on Nuedexta.”

Big Bucks for Big Pharma

Before Nuedexta, compounding pharmacists often combined dextromethorphan and quinidine to create a medicine for those with PBA, at the cost of less than a dollar a pill. Nuedexta, on the other hand, goes for over $12 a pill—and it is administered twice a day. Over half of all Nuedexta pills sold since 2012 have ended up in all types of long-term care facilities; sales from 2012 to 2016 spiked almost 400 percent.

Avanir allegedly instructed its sales force to target doctors aggressively in order to sell the drug. At times, the persuasion spilled over into illegal activity, such as compensating doctors with travel, meals, and payments for promoting and prescribing the drugs. Such compensations are known as kickbacks, and they are illegal under Medicare rules. One doctor in Ohio who received payments is being investigated for allegedly fraudulently diagnosing patients with PBA and receiving kickbacks for prescribing the drug.

The Latest Clinical Trial

As of mid-July, 2017, a clinical trial for the drug is ongoing in Phoenix (“Nuedexta in the Treatment of Pseudobulbar Affect in Patients With Alzheimer’s Disease”). We hope that the conclusions drawn by this study will shed new light on Nuedexta and its possible harm to those with dementia.

Seeking Truth, Securing Justice for Seniors

When someone you love has been hurt, it can feel like nothing will ever be right or fair again. When this happens, the South Carolina nursing home injury lawyers at the Louthian Law Firm can review your legal options and work with you to determine the most appropriate next step. While a lawsuit cannot restore someone’s health, a South Carolina nursing home injury claim can help recover the large sums spent on a neglectful or abusive nursing home, as well as medical bills created by that abuse or neglect. You may also be able to hold the abusers accountable for the pain and suffering they caused.

If a senior family member has had an adverse reaction to Nuedexta or to another drug, we also have valuable information for you regarding medical malpractice. We can review your legal options to determine the most appropriate next step. You should speak with an experienced attorney like the ones at the Louthian Law Firm as soon as possible. For a free consultation, call us today at 803-454-1200.

Look carefully at contracts you sign. These days, it’s likely you’ll find an arbitration clause in most of them. Arbitration is a way to resolve disputes using an independent, private third party, but it limits your ability to sue in court.

In an effort to shield themselves from being sued for elder abuse and wrongful death, nursing homes are inserting arbitration clauses into the agreements they require prospective residents to sign. If you don’t sign, you don’t get to live there. Once the agreement is signed by the resident, it has the force of a legal contract; such agreements are almost always upheld by the courts, in accordance with basic contract law.

But if the person who signed the agreement was not the resident, does the arbitration clause still apply?

The South Carolina Case of Thompson v. Pruitt Corp

In this case, a son and daughter had their mother admitted to a nursing home during January, 2011, that was owned by Pruitt Corporation. Because the mother was suffering from severe dementia, she was not legally competent to sign the nursing home agreements. South Carolina’s Adult Health Care Consent Act (AHCCA) permitted the children to make health care decisions for the mother. Therefore, the son signed the admission agreement and an arbitration agreement, along with other documents. It is important to note that:

  • The person being admitted did not sign.
  • The arbitration agreement was a separate document from the admission agreement.
  • Signing the arbitration agreement was not required for admission.
  • The arbitration agreement allowed the disclaiming of the agreement within 30 days.

Five hours after admission, the mother fell out of bed because of a broken bed railing, and she died as a result of her fall. The daughter filed a wrongful death suit against the nursing home. The nursing home tried to force arbitration, but was denied.

What Did the Courts Rule?

The trial court ruled that the son had no authority to execute an arbitration agreement for his mother, and the Court of Appeals of South Carolina affirmed the decision when it was appealed. Therefore, there was to be no binding arbitration, and the wrongful death case could move forward in the courts. The reasons given by the Court of Appeals were:

  • The son had no authority to execute an arbitration agreement for his mother because it was a separate document that did not deal with his mother’s health care, as covered by the AHCCA.
  • The arbitration agreement was also not a requirement for admission to the nursing home; therefore, it was not related to the mother’s health care.
  • Because of the mother’s dementia, she could not give her consent for her son to act as her agent in this matter.
  • Additionally, even if the mother had the ability to consent to her son acting as her agent in this matter, the standard power of attorney (POA) for health care does not permit the person wielding the POA to enter into an arbitration agreement. The reason is that such an agreement results in the waiving of the mother’s right to legal relief, and to a jury trial, in the court system.

It will be interesting to see what impact this ruling will have on future cases involving nursing homes and arbitration agreements.

When life goes wrong, we fight for what’s right.

When someone you love has been hurt, it can feel like nothing will ever be right or fair again. When this happens, the experienced South Carolina arbitration lawyers at the Louthian Law Firm can review your legal options and work with you to determine the most appropriate next step.

Arbitration is not an easy road to navigate. Arbitration cases have their own procedures, norms, and culture. It is of the utmost importance to find an attorney who is familiar with the process and who has a good track record both in court and in arbitration. Additionally, many South Carolina nursing homes and assisted living facilities are part of larger chains, complete with their own legal departments. Thus it is crucial that you have the legal assistance you need to secure justice.

Our attorneys can help you evaluate your case, protect your legal rights, stand by your side throughout the legal process, and get you the best possible results. For a free consultation, call the Louthian Law Firm today at 1-803-454-1200.